PSA screening for prostate cancer

When it comes to men’s health, one could argue that the prostate-specific antigen (PSA) test to screen for prostate cancer is the most critical test a man can have. It is also the most controversial. That’s because many experts believe prostate cancer is the exception to the rule that early detection of cancer saves lives. In fact, PSA screening may actually result in more harm than good.

Most men in the United States over age 50 get the PSA screening test, which was approved by the FDA in 1994. Many men have the test repeatedly. That’s probably no surprise, given that Americans value the early diagnosis of cancer along with the prompt and often aggressive treatments that follow. And for most types of cancer, that plan of attack makes sense.

But the PSA test can’t differentiate between slow-growing, harmless prostate cancers and the less common aggressive, potentially deadly tumors. In fact, the test doesn’t even diagnose cancer. Rather, depending on the numerical score, it may prompt a biopsy, which is the only way to detect cancer. If pathologists see cancer cells in the tissue sample, they try to estimate how aggressive the cancer is based on its appearance under the microscope.

The upside of PSA screening is that early diagnosis of aggressive prostate cancers can improve survival rates — tumors are caught before they significantly threaten survival. But when screening uncovers cancers that would never cause symptoms or harm during a man’s lifetime, it results in the major downsides of PSA screening: overdiagnosis and overtreatment.

That’s because a cancer diagnosis usually leads to treatment, and all prostate cancer treatments carry a substantial risk of side effects, including erectile dysfunction and urinary incontinence. As a result, though diagnosing aggressive cancers can be lifesaving, diagnosing harmless cancers may do more damage than good.

Two eagerly awaited studies — one conducted in the United States and the other in Europe, the results of which were published in The New England Journal of Medicine in March 2009 — were supposed to settle the debate over the value of the PSA test. (See “PSA screening and mortality” below.) Does PSA screening save lives by allowing doctors to treat aggressive cancers early? Or does it harm men who would never die from the disease by subjecting them to the side effects of surgery, radiation, or hormone therapy? Might a small subset of men benefit from screening? How often should screening be done? While each study offers some answers, the only definitive conclusion that seems to have come to the fore is that there is no “right” answer for everyone.

The American study

The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial began in 1993. Over the next eight years, 76,693 men between the ages of 55 and 74 with no history of prostate, lung, or colorectal cancers volunteered for the study, which took place at 10 medical centers in the United States. Investigators randomly assigned half of the men to be offered annual PSA testing for six years, along with an annual digital rectal examination (DRE) for four years. The PSA and DRE results of men in the screening group were reported to them and their physician. A PSA level above 4.0 ng/ml was reported as abnormal and usually resulted in a prostate biopsy. Men in the control group continued to receive their usual medical care, which may have involved some prostate cancer screening or none at all. In both groups, men who were diagnosed with prostate cancer were treated by their personal physicians. PLCO researchers found that men in the two groups had similar treatments.

After seven years, the researchers found a relative increase of 22% in the rate of prostate cancer diagnosis among the men offered regular PSA screening compared with those who received their usual medical care. Even though PSA screening increased the diagnosis of prostate cancer, it did not improve the prostate cancer survival rate, and there were no real differences in the numbers of deaths from other causes between the two groups. For about two-thirds of the men, complete follow-up data were available for 10 years, and the results after 10 years were similar to the findings after seven years.

The PLCO trial will continue until all the volunteers have been evaluated for 13 years. Researchers are compiling information on the side effects of treatment and participants’ perceptions of their quality of life. They will also track additional deaths among the study participants.

PSA screening and mortality

Andriole GL, Crawford ED, Grubb RL III, et al. Mortality Results from a Randomized Prostate Cancer Screening Trial. New England Journal of Medicine 2009;360:1310–19. PMID: 19297565.

Schröder FH, Hugosson J, Roobol MJ, et al. Screening and Prostate Cancer Mortality in a Randomized European Study. New England Journal of Medicine 2009;360:1320–28. PMID: 19297566.

The European study

Like the American study, the European Randomized Study of Screening for Prostate Cancer (ERSPC) began in the early 1990s. Investigators identified 182,000 men between the ages of 50 and 74 through population registries in seven countries. However, because some countries only enrolled men between ages 55 and 69, the ERSPC focused mainly on this core group, which totaled 162,243 men. Investigators then randomly assigned half of the men to be offered PSA screening once every four years, on average; those with a PSA level of 3 or 4 ng/ml or higher were referred for a prostate biopsy. The other half — the control group — had their usual medical care. Men who were diagnosed with prostate cancer were treated by their own physicians according to local guidelines.

After about nine years of observation, 214 men in the PSA screening group and 326 men in the control group had died from prostate cancer. The relative risk of dying from prostate cancer was reduced by 20% in the screening group and by 27% among those actually screened. What does that mean to the typical American man? In the United States, the lifetime risk of dying from prostate cancer is nearly 3 in 100, or 3%. A 27% reduction in the relative risk of dying from prostate cancer means that, with screening, the risk would drop to 2.19 in 100, or 2.19%.

However, that modest benefit came at a steep price: The researchers calculated that 48 men who are not at risk of dying from prostate cancer would have to be treated for screening to prevent one death from the disease over nine years. In other words, 48 men would risk the side effects of treatment to save one life.

As in the PLCO trial, ERSPC investigators will continue to track prostate cancer deaths and monitor treatment side effects and quality of life for the men.

Despite these major new studies, PSA testing remains a personal decision — one that can have dramatic ramifications. To help readers sort out the risks and benefits of PSA screening and learn more about the two studies, we interviewed Dr. Gerald Andriole, chairman of the Department of Urology at the Washington University School of Medicine in St. Louis and principal investigator of the PLCO trial, and Dr. Fritz Schröder, from the Department of Urology at the Erasmus Medical Center in the Netherlands and principal investigator of the ERSPC.

Dr. Andriole talks about the PLCO trial

We weren’t expecting any results from the PLCO trial to be published for a few years. Why did you decide to publish data now?

The PSA test was increasingly used in the late 1980s and early 1990s, and it received FDA approval for prostate cancer screening in 1994. Around that time, a drop in prostate cancer mortality occurred fairly quickly, and there have always been questions about whether that was due to screening or more aggressive and improved treatment. The early results of our study strongly suggested that the drop in prostate cancer mortality was more likely due to treatment than screening. That was the impetus to publish. The data and safety monitoring board didn’t mandate that we publish, but they did indicate that it could really be of benefit to people who are thinking about why we have seen such a reduction in prostate cancer mortality.

Also, in 2008, the U.S. Preventive Services Task Force recommended that doctors not screen men for prostate cancer after the age of 75. It was felt that the results from the PLCO trial supported that recommendation — or at least supported stopping screening in men with a limited life expectancy.

So you’re saying that the drop in the prostate cancer death rate is probably not due to PSA screening, but to treatment.

I think that more men with prostate cancer started getting treated — with surgery, radiation, or hormone therapy — and that was effective in prolonging their survival and increasing their chances of dying of something else. So I think it’s the combination of more treatment — and more aggressive treatment — that explains the drop in prostate cancer mortality in the 1990s.

What were the main operational and organizational similarities and differences between the ERSPC and the PLCO trial? How do you reconcile the differences?

In the PLCO trial, we screened with annual PSA tests for six years, and we reported results to the patient and his doctors. We did not mandate any evaluation after screening, and we did not mandate any treatment, even after a biopsy. In the European study, they had an explicit follow-up procedure after an abnormal PSA screening, though that procedure varied a little bit from country to country. Most of the European centers used a PSA of 3 ng/ml or higher as an indication for a biopsy, but that varied, and some centers prescribed ancillary tests, such as a DRE and transrectal ultrasound, at certain PSA levels.

With the ERSPC, I have a feeling that men who were in the screening group might have gotten slightly more aggressive treatment for prostate cancer than those in the control group because screening tended to happen at large medical centers. That’s where the men would get their biopsies, too, and if they had cancer, where they tended to be treated. But men who were randomly assigned to the control group were probably more likely to stay in their own community or small town for medical care, and it may have taken more time for them to get a biopsy and treatment. If you look at Appendix 7 of the ERSPC paper in The New England Journal of Medicine, you’ll see that higher percentages of men in the screening arm had surgery [33.7%] or radiation therapy [20%] than in the control arm [20.7% and 12.3%, respectively], though for quite a large number of the men, we don’t know what the treatment was [12.5% in the screening group and 26.9% in the control group]. Of course, you have to adjust for the fact that there were differences between the two arms in terms of the cancers’ stage at diagnosis, but it could be that some of the difference we see in mortality between the groups in the European study is due to these treatment differences rather than just screening differences.

In the PLCO trial, what happened when a man had a PSA test? How did you capture the information you needed?

We would mail a letter to the man and his physician that merely reported the PSA level or the DRE result with no specific recommendation about follow-up, though we did say that we considered a PSA level over 4 ng/ml to be abnormal and advised diagnostic evaluation. If a man had an elevated PSA, generally the first thing that his doctor did was repeat the test, and in some of those men, the PSA level was actually lower or had normalized. So if a man’s PSA level was slightly over 4 and then went down below 4 ng/ml, he would probably be monitored without treatment. But if a man in the PLCO trial was younger, had a family history of prostate cancer, or had a high PSA density, he was more likely to have had a biopsy.

We did a study analyzing who had a biopsy in the screening arm of the study, and we concluded that the biopsy rate following a positive PSA screening test in the PLCO trial was about the same as the national rate. It’s true that it took about two to three years for most of the men to have a biopsy following an abnormal PSA screening test, but that’s real life. Many of them have other health issues that need more urgent attention.

In addition to obtaining all of the records related to the follow-up of men with abnormal PSA tests, we periodically assess participants’ compliance in getting screening, look for changes in tumor grade and Gleason score over time, and calculate the overall prevalence of cancer. (For more details about follow-up and compliance with the PSA screening regimen, see “PLCO participant follow-up” below.)

PLCO participant follow-up

Grubb RL III, Pinsky PF, Greenlee RT, et al. Prostate Cancer Screening in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: Update on Findings from the Initial Four Rounds of Screening in a Randomized Trial. BJU International 2008;102:1524–30. PMID: 19035857.

Pinsky PF, Andriole GL, Kramer BS, et al. Prostate Biopsy Following a Positive Screen in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Journal of Urology 2005;173:746–50. PMID: 15711261.

So it sounds as if the PLCO trial was designed to mimic what happens in terms of follow-up in a real medical practice.

Exactly. We have a screening site here in St. Louis. We enrolled about 17,000 patients, and quite a number of them ricochet back and forth from their family doctor to our center for a biopsy and treatment, but not all of them. There are patients who came here for screening from two to three hundred miles away. Generally, they saw a urologist in their community to follow up.

Have you done any kind of analysis or comparison of patients who are treated in the community versus those who are treated in large academic medical centers? That would lend credence to your observation about treatment differences in the ERSPC.

We have not done that. I don’t know if doing such an analysis would show anything. But, in the PLCO, we have analyzed who received treatment, the type of treatment, at what age, and what other medical conditions they had, and we could find no difference between the two arms of the study.

Was there any difference in Gleason scores between the screening and control arms of the study?

Yes. As you would expect, the Gleason scores tended to be lower for cancers discovered in the screening arm. But keep in mind that the Gleason scores were not assigned or reviewed at one central facility, so there may have been some variability in determining the scores. We are in the process of trying to analyze Gleason scores centrally, and we’ve collected about 3,000 radical prostatectomy samples to review.

The AUA position on PSA testing

In response to recent research, including findings from the PLCO trial and the ERSPC, the American Urological Association (AUA) updated its “best practice” statement on PSA testing in April 2009. Unlike the guidelines it issued in 2000, the new document states that PSA testing should be offered to men ages 40 and older who have a life expectancy of at least 10 years. The result would provide a baseline reading, offering a point of comparison if additional tests are done in the future. Men who have a PSA test should be well informed about the risks and potential benefits of screening and should understand that cancers may be detected that don’t need immediate treatment.

A second notable change: the AUA no longer recommends a single PSA threshold above which a biopsy should be obtained. Rather, the decision to proceed with a biopsy should take multiple factors into account, including free and total PSA, PSA velocity, and PSA density; the patient’s age, family history, and race or ethnicity; results of any previous biopsies; and any other medical conditions the patient has.

The European Association of Urology also issued a position statement on screening for prostate cancer. To access it, visit www.uroweb.org/press/pressreleases, and then click on the April 16 press release.

You’re not reviewing biopsy samples?

Not at the moment. We have a big tissue repository associated with the PLCO trial, and a laboratory at UCLA was making slides with tissue from a number of cancers, including prostate cancers treated with radical prostatectomy, and we asked them to make extra slides for us so that we could do this central Gleason score review.

Was there any consistency in the number of tissue samples, or cores, taken during biopsies or in how the biopsies were done?

We do not know, but suspect there is no significant difference between men in the screening and control groups. While some critics have said that we should not leave any of these issues to chance or a given practitioner’s preference, in reality, patients and practitioners are different. As a urologist, my main concern may be a man’s elevated PSA. For his family doctor, the No. 1 priority might be the man’s diabetes and high cholesterol, so the elevated PSA gets put on the back burner. He might watch the PSA to see if it goes up, and he might do a biopsy at a later time, but that might not be his primary concern at the moment. It may not be consistent, but it’s realistic. And according to the analyses we’ve done thus far, the biopsy practices in the PLCO trial seem to reflect good medical judgment.

Statistically speaking, what was the PLCO trial originally designed to show?

A 20% reduction in prostate cancer mortality in the screening arm versus the “usual treatment” arm, the same as with the ERSPC. Our original enrollment goal was 75,000 men, and we accrued a bit more than that.

Another important thing to emphasize is that the men in the study who were screened for prostate cancer were also screened for lung and colorectal cancers. We didn’t have three separate cohorts. We probably could have enrolled fewer patients to assess screening for lung and colorectal cancers, but we needed 75,000 men to have a study that would be strong enough to find a difference in prostate cancer mortality with screening, if one existed.

What about cause of death? Was that centrally reviewed or determined by individual physicians?

There was a central committee that reviewed clinical and autopsy data. Over all, about 15% of the men in the study have died, and if they had prostate, lung, colorectal, or any metastatic cancer, the committee reviewed the data to confirm the cause of death. Committee members are “blinded,” so they don’t know who had a radical prostatectomy, for example, or who was in the screening arm or the control arm. After seven years of follow-up, only 94 deaths have been attributed to prostate cancer, with 50 deaths in the screening group and 44 deaths in the control group.

But with only 94 deaths, if a few of them were reclassified, it could change the study’s results.

That’s unlikely. There were only small differences between what the death certificate said and the death committee’s review. We’re going to continue to follow men who have not died, look at the age of the men who are dying and any other medical conditions they have. There could be subsets of men who will benefit from screening. Remember, in the European study, only men in specific age groups benefited from screening.

Let’s talk about the contamination rate, which is the percentage of participants in the control group who shouldn’t have had a PSA test or a DRE but did.

Critics could say that the level of screening in the control group could be substantial enough to water down any modest effects of screening in the screening group. In our control group, the rate of PSA testing was 40% in the first year, and it increased to 52% by the sixth year. But even with that magnitude of contamination, the trial is still adequately powered to find a 20% or greater drop in prostate cancer mortality due to screening, if one exists.

What about screening before the study started?

About the same number of men in each group had had a PSA test in the three years before the trial began — 34.6% in the screening group and 34.3% in the control group.

Did any of them have a biopsy before the study started?

About 4% to 5% of the men had actually had a biopsy prior to entering the PLCO trial and being randomly assigned to the screening or control group. That’s not a huge number, but in retrospect, we probably should have excluded them from the study. When you add that to the amount of screening prior to the start of the trial, it could take longer for this trial to show a difference in mortality with screening.

Are the participants still being screened?

No. But we contact each participant yearly and do an annual health survey. We want to follow each person for a minimum of 13 years.

What did you think of the media coverage of the studies?

It’s been a confusing story. You have one positive study and another one that’s not positive, so what do you tell patients? I would say that these are early mortality results. The PLCO trial does not yet tell me whether younger patients will or won’t benefit from screening. We need to wait longer to find out. But in my mind, the converse is true: if you are elderly or you have other medical conditions and your life expectancy is only about 10 years, PSA screening probably isn’t necessary, regardless of your actual age.

I really liked the comment in the ERSPC study paper that 48 men would need to be treated to prevent one death from prostate cancer. That was eye-opening, and it’s why we need to be smarter about what we’re doing and who gets treated. Once a cancer is diagnosed, there’s a real tendency among patients and doctors to treat it.

We need to find ways to determine which cancers are potentially lethal and need treatment and which ones can be left alone.

That’s right. Looking at cancer under the microscope and predicting how aggressively it will behave seems like 100-year-old technology. We’ve got to do better. But keep in mind that the study was designed in the early 1990s, and we didn’t know as much then as we know now about the implications of various PSA levels, PSA velocity, and other factors.

You’ve spent a substantial amount of your career on this study. It must be disheartening to hear people criticize it and say it was poorly planned.

I think some people have criticized it because it doesn’t show what they want it to show. But it’s not over yet. In time, it may well show that screening saves some lives. And even when a trial has a negative result, we can learn from it. With the PLCO trial, we want to look at when it might make sense to pursue PSA screening — when it should be started and when it should be stopped.

Have you changed the way you practice as a result of either of these studies?

I feel much more confident in stopping screening of men who probably won’t live another 10 years. I’m also much more inclined to suggest active surveillance, to watch men with prostate cancer and do another biopsy a year or two later to see whether they have an aggressive cancer.

Any parting comments?

What’s sobering is that even if PSA screening reduces prostate cancer mortality, the cost of screening is extraordinarily high in financial and human terms. We could save money by stopping screening at a certain age or when life expectancy hits a certain point. We could reduce the economic and human toll if we screen more thoughtfully and, when we find cancers, treat them a little less aggressively, if at all.

Determining cause of death

De Koning HJ, Blom J, Merkelbach JW, et al. Determining the Cause of Death in Randomized Screening Trial(s) for Prostate Cancer. BJU International 2003;92(Suppl 2):71–78. PMID: 14983960.

Dr. Schröder talks about the ERSPC

When we interviewed you several months ago,* you didn’t think you’d have results until 2010 or 2011. What happened that allowed publication to move forward so quickly?

Right after we spoke, our data monitoring committee said that we had a statistically significant difference in prostate cancer mortality between the control and screening arms, so we had to stop recruiting volunteers but continue follow-up. And according to our original plan, that meant we were to publish the findings to date.

You reported study findings on men who were between the ages of 55 and 69 when they entered the study. What about men in the study who were outside that age range?

That age range was set in our protocol when we forged the European collaboration including all of the centers in 1994. Some of the centers also gathered data on men ages 50 to 54 and 70 to 74; data on these subsets are included in our report but were not tested for statistical significance.

Did you have any discrepancies about cause of death in your study?

There is total unanimity about the causes of death among study participants because all of the centers used the same algorithm, which was published, to determine cause of death throughout the study. [See “Determining cause of death” above.] We looked only at prostate cancer information and whether or not the man was alive; committees looking at cause of death were blinded with respect to the arm of the study the person was in.

What did you think of the press coverage of your study and the PLCO trial?

I thought it was a pity that the two studies were looked at in the same way. There’s one poorer study and one better study. We weren’t scheduled to have sufficient follow-up to find a difference until we had analyzed all of the data through December 2008, but we found it two years early. So, The New England Journal of Medicine put a lot of pressure on us to explain exactly what the power calculations of our study were. We were very surprised to see that statistical power isn’t even mentioned in the PLCO trial. Estimates of the power of that study are so low that we’re unlikely to see any significant differences in future analyses.* The main reason for that is that the difference in the proportion of men undergoing screening in the two arms of the PLCO trial is only 33%: 85% of the men in the screening group were actually screened, and 52% of those in the control group were screened. The PLCO trial should’ve excluded previously screened men from the study to improve the power of the study.

The study noted that you’d have to screen 1,410 men and treat 48 to save one life in nine years, prompting many men to ask whether screening is worthwhile. What do you think? Should medical practice be altered, given these findings?

Absolutely, yes. Until now, we only knew the disadvantages of screening; we didn’t know the potential advantages. We now know that PSA screening reduces the risk of death from prostate cancer by 20% — and by 27% in men who are actually tested.* But that message has to be balanced with the enormous amount of overdiagnosis and overtreatment — diagnosing and treating prostate cancers that aren’t likely to cause health problems during a patient’s lifetime. People who are overdiagnosed and overtreated suffer from the side effects and the costs and efforts involved in getting treated without getting any of the benefits.

*Editor’s note: When accounting for all men in the screening arm of the ERSPC, screening reduced the rate of prostate cancer mortality by 20%. But some men in the screening arm of the study weren’t screened. In an analysis of men who were actually screened, the rate of prostate cancer mortality dropped by 27%.

One of the major advances of our study is that we can offer patients some information about how many men need to be treated to save a life. With breast cancer, the number of patients that need to be treated to save one life is around 10. For prostate cancer, due to the enormous amount of overdiagnosis, it is 48 over nine years. That’s a number that’s difficult to accept.

But our report did not specifically outline the factors that determine the number needed to treat. So, for example, if we didn’t do biopsies on the men who had a PSA between 3 and 4 ng/ml, which was about 8% of the men, we wouldn’t have detected as many cancers. That would bring down the number needed to treat considerably — and probably make it more acceptable.

Indolent prostate cancer

Steyerberg EW, Roobol MJ, Kattan MW, et al. Prediction of Indolent Prostate Cancer: Validation and Updating of a Prognostic Nomogram. Journal of Urology 2007;177:107–12. PMID: 17162015.

What do you tell a patient who has had radiation or a radical prostatectomy and asks you, “Do you think I really needed to be treated?”

I think patients are justified in asking that question. From now on, once the biopsy is done, I would use our risk indicator or another nomogram to help decide whether a prostate cancer needs treatment; we did a study that showed 49% of men diagnosed with prostate cancer through screening have indolent disease. [See “Indolent prostate cancer” above and “How aggressive is my cancer?” below.] Identifying indolent cancers won’t decrease the number of cancers that are diagnosed, but it will decrease the number requiring active treatment. That’s a good beginning.

If someone asked me that question retrospectively, I would go back to his clinical findings, log on to the risk indicator on my laptop, and fill in the five key numbers. If I found that the patient’s chances of having an indolent tumor were 68%, knowing what we know now, I probably would have advised him not to be treated.

How aggressive is my cancer?

Statistical tools called risk calculators, or nomograms, offer help in understanding the nature of a patient’s cancer (indolent vs. aggressive) and guidance in making treatment decisions. Two such indicators can be accessed online. One, developed using data from the ERSPC, is available at www.uroweb.org. The other is available at www.mskcc.org/mskcc/html/10088.cfm.

Note that risk calculators have limitations and should be used in consultation with a physician, who can offer advice on treatment decisions.

What stance should the American Urological Association,* the American Cancer Society, and other organizations take with respect to routine PSA screening for men at average risk of prostate cancer?

We know now that screening saves lives. In the United States, about 30,000 men die of prostate cancer a year. Among those who consent to it, screening reduces the risk of death by 27%, which is more than 8,000 lives per year. That’s a large number. But we need to be clear that if prostate cancer is diagnosed, there’s a big chance that the tumors are insignificant or not life-threatening. To put that into perspective, men need to talk to their health care providers.

*Editor’s note: At its annual meeting in April 2009, the American Urological Association issued a “best practice” statement with regard to PSA testing. For details, see “The AUA position on PSA testing” above.

Many men may look at the relative risk of dying from prostate cancer, which is low, along with the negative findings from the PLCO trial, and wonder why they would have a PSA test in the first place.

Again, you shouldn’t mix the PLCO information with our data. We were surprised that these two studies were published together, with the implication being that they employed the same level of scientific rigor. The PLCO trial is very unlikely to ever show a significant difference between the screening and control groups. It’s easy to point out why. For one thing, 44% of the men in the study had had at least one PSA test before they were randomly assigned to a study group. That takes away the potential for the study to detect cancer in a large number of the participants. And the contamination rate in the PLCO trial was 52%.

What was the contamination rate in your study?

We estimate that our contamination rate was approximately 20%, but that varies a bit among the countries based on local attitudes and health care policies. The rate of effective contamination — the number of asymptomatic men in the control arm who had their PSA tested outside of the trial, subsequently had a biopsy, and were then diagnosed with cancer — was only 3%. [See “PSA contamination” below.]

PSA contamination

Otto SJ, van der Cruijsen IW, Liem MK, et al. Effective PSA Contamination in the Rotterdam Section of the European Randomized Study of Screening for Prostate Cancer. International Journal of Cancer 2003;105:394–99. PMID: 12704675.

Are you still enrolling patients in the ERSPC?

No. We locked the database on Dec. 31, 2008, but we will continue to evaluate the participants and publish our data, probably every two years. Of course, we’ll have to take into account increasing contamination of the control group over time, and we’ll make a better effort to quantify contamination. But any contamination that occurs in the control group now will have very little influence on mortality. That’s because any cancer cases in the control group that are detected now by screening are very unlikely to decrease the mortality rate within the next two to four years.

In light of the most recent findings, what do you tell patients about screening?

If a man comes to me and says, “I’m thinking about having a PSA test,” I tell him that screening will reduce his chance of dying of prostate cancer by 27% over nine years. Then I explain the downside, telling him that there’s a big chance that if he’s diagnosed with cancer, he will have indolent disease. I would then advise him not to undergo aggressive treatment. Even in cases of aggressive disease, his chances of being overtreated are still considerable.

In the United States, PSA screening has typically been done on an annual basis. Did you come to any conclusions about how often men should be screened?

We are very worried about the effect of our paper on screening. If people conduct screening more often or decrease the amount of time between tests, we’ll have more biopsies. That is something that we’d regret because it would further increase the rate of overdiagnosis.

We believe that future screening intervals should be determined based on a PSA value at a certain age. For example, a 55-year-old man with a PSA of 1.5 ng/ml could be screened less often than another man of the same age with a PSA of 3.5. The volume of the prostate should also be taken into account; a larger gland produces more PSA. Annual screening may be useful for people at high risk of prostate cancer. But the average man with a low PSA (below 1 ng/ml) and a normal DRE could be screened every four years or so.

Will you publish papers about differences in quality of life between participants who were treated and those who weren’t?

The papers are being written. They may show that screening doesn’t make sense when you factor in changes in quality of life due to treatment. But at 11 years, we are likely to see an increased difference in mortality with screening, and perhaps when we factor in quality of life, then the picture will change.

Do you think more men will be screened as a result of this study?

It will depend on how physicians in different countries respond to this new information. In my view, it would make a lot of sense if more people decided to be screened because they could reduce their risk of dying of prostate cancer by 20%. Personally, I would decide to be screened on the basis of these data. When I started this study in 1991, I wasn’t sure whether screening would be helpful in any way, but the uncertainty I had is now gone.

Originally published September 2009; last reviewed March 17, 2011.

Comments
1
James

Men beware!

Read the sad truth about prostate cancer testing and treatment.
Prostate cancer lies, exaggerations, deception and elder abuse.
A prostate cancer survival guide by a patient and victim.
Men, avoid the over diagnosis and unnecessary treatment of prostate cancer.
Read about prostate cancer patient exploitation, testing and treatment dangers.

If you don’t want to read this entire document, just read the bold print. One day your life or your quality of life may depend on it.

Revised April 26, 2017

In my opinion:
Read the hard facts about prostate cancer testing and treatment that no one will tell you about, even after it’s too late. This is information all men over 50 should have. Also, anyone concerned about cancer in general, clinical trials, medical mistakes, exploitation, elder abuse, HIPAA laws or privacy issues should read this document. Prostate cancer patients are often elderly, over treated, misinformed and often exploited for profits by predatory doctors. The testing, treatment and well documented excessive over treatment for profit of prostate cancer often results in devastating and unnecessary side effects and sometimes death. At times profit vs. QOL (quality of life).

Per some studies:
1. Studies have verified more deaths caused from prostate cancer testing and treatment then from prostate cancer itself.
2. Extensively documented unnecessary testing and treatment of prostate cancer for profit or poor judgment by some doctors in the USA.
3. Medical mistakes are the third cause of deaths in the USA (over 251,000 deaths a year, over one million deaths in 4 years) more then suicide, firearms and motor vehicle accidents combined.
4. 1 man in 6 will be diagnosed with prostate cancer in his life.
5. About 233,000 new cases per year of prostate cancer.
6. About 1 million dangers prostate blind biopsy’s performed per year in the USA.
7. 6.9% hospitalization within 30 days from a biopsy complication.
8. About 1.3 to 3.5 deaths per 1,000 from prostate blind biopsies.
9. .2% to 1.2% deaths as a result of prostate cancer surgery.
10. 60% had a prescription filled for an infection after a Biopsy.
11. Black men are at an increased risk of prostate cancer.
12. Prostate cancer patients are at an increased risk for fatigue, depression, suicide and heart attacks.
13. Depression in prostate cancer patients is about 27% at 5 years, for advanced prostate cancer patient’s depression is even higher.

Excuse the generally accurate humor and sarcasm. Its intent is to entertain and educate while reading this possibly laborious text.

Prostate cancer patients are often elderly and exploited for profit, the treatments offered has horrible side effects, and newer treatment options are either unavailable or not offered to patients or available outside the USA. Prostate cancer is often slow growing and of low risk and can just be monitored. Often no treatment is the best treatment. Over testing and treatment has been verified by numerous experts, studies and investigations, documentation, etc.

The medical field is now alluding to the fact that prostate cancer testing and treatment may be do more harm then good. The U.S. Advisory Panel is now recommending for prostate cancer PSA testing and screening: “letting men decide for themselves after talking with their doctors”. However this may not protect men from predatory doctors exploiting them. This may only shift the accountability to the victims, patients are not doctors. Patients usually follow a doctor’s recommendation. Do you think any regulatory agency will stop the exploitation of elderly men with a high PSA or prostate cancer or approve new treatments at the risk of financially bankrupting thousands of treatment facilities and jeopardizing thousands more jobs? Do you think any regulatory agency will set guidelines for testing and treatment at the risk of upsetting the doctors who are over treating?

If a surgeon is financially responsible for a building lease, a large staff or an oncologist is also responsible for a lease on multimillions of dollars in radiation treatment equipment, do you think they would be more or less honest about the benefits and hazards of treatment? Do you think the profit margin would compromise some doctor’s ethics? Typically, what is the purpose in over testing and treating a cancer that often will not spread and the testing and treatment frequently causes lower QOL (quality of life), ED, incontinence, depression, fatigue, suicide, etc if it was not extremely profitable.

A 12, 18 or 24 core blind biopsy, holey prostate! Prostate blind biopsies are dangerous. Men with a high PSA tests result are often sent to an urologist for a blind biopsy. Men should be told about other options: Percent free PSA test, 4Kscore test, PCA3 urine test or a MRI test before receiving a blind biopsy. These tests can often or always eliminate the need for a more risky and invasive blind biopsy. Insertion of 12, 18 or 24 large holes (most of the time) through the rectum into a gland the size of a walnut, a blind Biopsy can result in (per studies) prostate infections, a risk of permanent or temporary erectile dysfunction, urinary problems, hospitalization from infections and sometimes even death from sepsis (About 1.3 to 3.5 deaths per 1,000 from blind biopsies). There is also controversy that a biopsy may or may not spread cancer because of needle tracking. A blind biopsy can also increase PSA reading for several weeks or months, further frightening men into an unnecessary treatment. Blind biopsies are almost never performed on other organs. One very prestigious hospital biopsy information states “Notice that your semen has a red or rust-colored tint caused by a small amount of blood in your semen”. Another large prestigious hospital states “Blood, either red or reddish brown, may also be in your ejaculate.” These statements are often an extreme exaggeration (mostly lies). Very often after a biopsy a man’s semen will turn into a jet black goo. This could be an unpleasant surprise for a man and especially for his unsuspecting partner. However if a biopsy is performed before Halloween or April Fools’ day this may be of some benefit to a few patients. If some very prestigious hospitals are not factual about the color of semen, what other information is not being disclosed or misrepresented?

Bone scan scam: Prostate cancer patients are often sent for a bone scan. A bone scan has about a 13% chance of having a false positive and only 3 men in 1,000 have bone cancer who have a bone scan. Bone scans may often be unnecessary in lower risk prostate cancer patients.

Low risk cancer patients or patients with advanced age are often sent for aggressive treatment by some doctors when monitoring is usually a better option. An extreme example of overtreatment is one SBRT radiation clinical trial. Prostate cancer patients (victims) where intentionally treaded (fried) with a huge dose (50Gy total, 5 fractions) of radiation resulting in disastrous long term side effect for some of these men. A large percentage of prostate cancer patients in this clinical trial had low risk prostate cancer and may have not required any treatment at all.

Clinical trials may or may not be hazardous to patients. The goal of a clinical trial is to gather information; the intent is not necessarily to help or cure patients. In a clinical trial, if someone is given a treatment that will harm them (as in the above example) or given a placebo in place of treatment or needed treatment is withheld, the patient may be deceived or harmed. Investigate before you participate in any clinical trial. Often drug company’s get your information from medical databases and pharmacy information to lure people into clinical trials, soliciting people with letters and postcards in the mail. This is often a HIPAA violation. If you call about a clinical trial your phone conversation will probably be recorded “for quality purposes” including your medical and personal information. You will not be told if you are getting a drug or a placebo.

Your privacy and confidentiality may be just an illusion: You may have little privacy and confidentiality! Under the HIPAA law all access to your records is allegedly by a “Need to know” basis only, this is another exaggeration. Prostate cancer patients are asked to fill out a series of EPIC questionnaires and other standard questioners. The EPIC questionnaire asks several intimate details about patient’s sex life, urinary and bowl function. By a prostate cancer patient completing an EPIC questionnaire may be able to assist his doctor, nurse, office workers or database track his progress or decline. By refusing to fill out these questioners and supplying other unnecessary information one can help insure his privacy, dignity and insure he do not unknowingly become part of a study or clinical trial or other collective survey or have his information forwarded to multiple databases. He may be told these questioners and records are “strictly confidential” (as stated in some EPIC questionnaires); this statement is misleading. Most of the time a patient has no idea who has access to medical records or why the records are being looked at. Who has access to your medical records? Probably everyone that works in a medical office or building has access to the records, except you (often you the patient may have limited or no access). Access may include/however not limited to non-medical employees, office workers, bookkeepers, janitors, insurance companies, temporary high school or college interns, volunteers, etc. This may also include other medical facilities, programmers, hackers, researchers, etc. Very often records are placed on a Health Information Exchange (HIE) or server, dozens, sometimes even hundreds or thousands of people may have access to medical records. Some major databases like SEER are linked to Medicare records to determine “the final outcome” for researchers, studies, drug companies-often for clinical trials offers, etc. SEER is an appropriate name for this database! Your drug prescription history can also be tracked by insurance companies and others. Records may be packaged with others and offered for sale, this does often happen. Your medical records can be downloaded to multiple servers all over the world to countries that do not have any regulations for privacy. If a doctor, patient or insurance company is involved in a criminal or civil case, medical records may become public court or law enforcement records. Your records can be acquired by insurance companies if you apply for disability. If a patient has radiotherapy he may have a photo taken before treatment to verify identity. All patients should get a copy and read any confidentiality disclosures statements (HIPAA statements). Patients can also become the victims of financial or medical Identity theft. Under the HIPAA laws you are entitled to a copy of all your medical records, however if you try to obtain a copy of extensive records as in a hospital stay you may be met with resistance. I recently went to a new optometrist for glasses and I was given a form that asked details about my heritage, including my mother’s maiden name and a form for my complete medical history. Your records can also be accessed by anyone (trainees, volunteers, students, interns, minors and adolescent people as young as 16 years of age, etc) “for training purposes” or any other reason, all without your consent. This gives kids a chance to play doctor and nurse in a real doctor’s office with real patients. A list of what a high school intern is allowed to do to patients: “learning simple medical procedures, watching surgeries, shadowing doctors (including seeing patients, possibly you), working in hospitals, interacting with patients, and more.” They can also read all records about your prostate problems, your wife’s hemorrhoids and your daughters yeast infections or any files for any patient, all within the HIPAA guidelines. These people do not have to be employed by the facility or have a background check. My family doctors office has summer time high school interns with full access to all records. One high school intern signed me in, took my temperature, weight, blood pressure and logged it in my chart. Would you like to have a high school or college student that possibly lives in your neighborhood or attends school with your children read over your extensive family member’s medical records and personal information? How much curiosity or self control does a high school or college student have? I also went to a hearing aid center in a department store to get a free hearing test and was given forms inquiring about personal information and my complete medical history. This is information I do not want filed in a department store. All patients should avoid supplying unnecessary information whenever possible. Supply relevant information only when filling out forms. In the USA identity theft is very common, growing problem and is often financial devastating. Medical forms can be a good source of information for thieves. Recently my friend with arthritis in her hips received a letter offering a clinical trial for a new medication; coincidently looking for patients with hip and knee arthritis. How did this company determine she and not her husband or other family member was a prime candidate for this new drug study without violating any HIPAA privacy laws? Numerous exceptions (loopholes) appear within the HIPAA laws regarding you privacy. Even without HIPAA privacy law violations, records can be accessed by multiple people and appear in multiple databases. Sometimes medical phone calls are recorded “for quality purposes”. Calls about a clinical trial, calls to a large clinic toll free number and calls to insurance companies may be recorded. These conversations can include confidential or medical information. Some of the Obamacare goals sought after everyone’s medical records on servers so they could be accessed by any medical facility or doctor. HIPAA laws are deficient and often will not protect your privacy. Your privacy and confidentiality is not that secure. I believe the medical field has little regard for our privacy, especially if it is in conflict with training, research, studies, profit or other objectives. If you’re a public figure, celebrity, rich or famous you may be subject to numerous people wanting to see your medical records. Also if you are known to or an acquaintance of anyone with access to your records (neighbor, co-workers spouse, etc) they would possibly want to get a look at your medical records. You are naive if you believe otherwise or that your records are secure. The same also applies to pharmacy workers and your prescriptions.

A patient’s dignity: Prostate cancer testing and treatment is often degrading and demoralizing. EPIC questionnaires can be counterproductive impact a patient’s dignity, privacy, confidentiality, and self image. EPIC questionnaires probably have an increased potential and greater impact on patients for privacy violations because of its format, nature and personal content (potential for HIPAA privacy law violations). Patients may mistakenly believe the EPIC questionnaire is a requirement to be filled out. Also the term “strictly confidential” can be misleading and ambiguous. One blogger patient posted he filled out and turned in his “strictly confidential” EPIC questioners only to have every female office staff member read it and ogle him. Resulting in him not filling out any more EPIC forms or any other forms and he stated that he became very uncomfortable and evasive with the entire office staff. The drawbacks of this form seem to outweigh any potential benefit for some patients. Medical tests and procedures can be degrading and embarrassing for both men and women. Many women prefer or will only see female doctors or gynecologists, about 50% to 70%. Over half of men prefer a male doctor. (Per some respected doctors: Men stay away from medical care in large numbers because of privacy and dignity. Many men still avoid medical care because of embarrassment. Honest answers will often not be given if asked by a female doctor or nurse.) What percent of old men will feel comfortable consulting a female doctor, nurse or office worker about his prostate problems, ED, etc or would want an invasive test or procedure performed by a female?

The most common treatment options for men with prostate cancer are radiation, Brachytherapy, surgery, cryotherapy and hormones (ADT). Sometimes chemotherapy, immunotherapy and castration (orchiectomy) are used. A combination of treatments is often used. Most or all of these treatments have long term or short term side effects. Often men are not told about all of the true risks and side effects or they are downplayed for both a blind biopsy and treatments.

LDR Brachytherapy is permanent radioactive seed implant. This treatment procedure implants about 50 to 100 radioactive seeds in the prostate, sometimes resulting in urinary problems. The patient will literally become radioactive for months and up to 2 years. The patient may set off radiation alarm and also possibly metal detectors at airports. He will also be required to use a condom, have no close contact with pregnant women, infants, children and young animals or pets for months or longer. Occasionally he may even eject radioactive seeds during sexual activity or urination. The patient will become like a walking Chernobyl, having radioactive scrap metal and emit radiation from his crotch. He will also be required to carry a card in his wallet stating he is radioactive. The videos of this procedure seem to be disturbing and bizarre. A catheter will also be required for a short time. However allegedly LDR Brachytherapy seems to have less sexual side effects than some of the other treatments available.

Men are sometimes prescribed hormone therapy (ADT therapy), AKA chemical castration as an additional or only treatment. Hormone (ADT) therapy is sometimes over prescribed for profit, per some studies. Hormone therapy is often very expensive (may be profitable for doctors if provided at the doctors office and not a pharmacy) and can have horrible, strange and devastating side effects, feminization, fatigue, weight gain, depression, etc. His penis could shrink and his testicles can completely disappear, he may grow breasts. This treatment can have so many mind and body altering side effects that doctors will often not inform patients about all of them. Men are sometimes castrated (orchiectomy) as a cancer treatment to reduce testosterone. Studies (Medicare and financial) have documented doctors do over prescribe ADT therapy for profit (depending on Insurance payout rates/profit margin). When insurance payment reimbursement for ADT decreased so did the number of patients being prescribed ADT therapy! Per Wikipedia: “in patients with localized prostate cancer, confined to the prostate, ADT has demonstrated no survival advantage, and significant harm, such as impotence, diabetes and bone loss. Even so, 80% of American doctors provide ADT to patients with localized prostate cancer.” Overtreatment with ADT is extremely profitable, unfortunate and avoidable.

Nerve sparing Robotic-assisted DaVinci surgery is touted as being a better treatment and having fewer side effects, this is usually an exaggeration. The nerves can not always be spared. Robotic surgery can result in a faster initial recovery. Long term risk of incontinence, fatigue, ED, etc is about the same as conventional surgery. Patients undergoing surgery are at a very small risk of developing post traumatic stress disorder (PTSD) and about a 25% chance of long term or permanent fatigue. Also .2% to 1.2% risk of deaths as a result of prostate cancer surgery or medical mistakes. Patients can have unrealistic expectations about the results and regret the surgery treatment option. The ED rates and other side effects are often understated to patients.

Patients should not be naive: Medical mistakes are the third cause of deaths in the USA (over one million deaths in 4 years). Medical mistakes cause more deaths then suicide, firearms and motor vehicle accidents combined. Countless other patients have been harmed by medical mistakes. If you are having surgery, brachytherapy, a biopsy or a procedure take precautions if possible. Have someone qualified or knowledgeable monitor you and your medications, etc. Doctors, nurses and technicians can be profit motivated, use obsolete procedures, be lazy, incompetent, make mistakes and be apathetic or rushed. Occasionally harm can be done or not prevented with intent. Drug abuse is often a problem with some medical workers because of easy access. Doctor’s offices and clinics can see many patients in a relatively short amount of time. This may be a disadvantage to patients, empathy and quality of care can sometimes be compromised. Sometimes a nurse, medical assistant or an office staff member may be the person that overseeing much of a patient’s cares. I personally know of at least 5 medical staff that I would consider incompetent, abusive, mentally disturbed or drug abusers that work in doctors offices and hospitals and I now understand why medical mistakes are the third leading cause of deaths in the USA. TV and sometimes the public seem to idolizes doctors, nurses and caregivers, however health care workers seem to have the same amount of abusive or incompetent workers as other occupations. I have also had excellent doctors and nurses. however this may not protect you from the bad ones. What are the main reasons nurses get fired: 1. Prescription drug abuse (because of easy access to drugs). 2. Too many mistakes. 3. Code of conduct and privacy violations. 3. Bad attitude. 4. No proper licenses 5. Abuse of patients. Patients should be aware that sometimes QOL (quality of life) may be secondary or an absent goal in treatment. Sometimes overtreatment for profit or to prevent an unlikely death or metastization from low risk cancer may be the primary or the only goals of cancer treatment.

A blind biopsy or treatments are often worse then the disease: Resulting in Chronic/permanent fatigue, incontinence, depression, sexual dysfunction and sometimes death. Hormone therapy may have an extensive list of side effects that can be devastating for men. Biopsies and treatment are degrading, stressful and often unnecessary. Many men may not be prepared or have unrealistic expectations about the outcome, physical and psychological impact of testing and treatment.

The risk of long term chronic and permanent fatigue (that can result in depression) is almost always understated if mentioned at all to many patients. Per some studies and depending on your treatment; the risk of long term or permanent fatigue is about 25% to 60%. Radiation with Hormone therapy has a high risk of fatigue. Long term fatigue also increases the risk of clinical depression and suicide.

The prostate may have unknown or undocumented functions. The removal or destruction of the prostate often results in chronic fatigue, loss of libido and depression that often can not be accounted for.

In my opinion: Castration, ADT hormone therapy (chemical castration), LDR Brachytherapy (radiation seed implant), radiotherapy, surgery and blind biopsies are often psychically and emotionally brutal, traumatic and disturbing. These types of treatments are primitive and almost beyond belief in today’s world of advanced technology. Newer treatments like, HIFU, hyperthermia, Boron Neutron capture therapy, focal Ablation (only treating the cancer and not the entire prostate) and orphan drugs should be approved and used when appropriate. Biopsies should be limited to selective MRI guided samples only; blind biopsies should seldom or never be performed.

Approved advances in prostate cancer treatment mostly consisting of newer more accurate radiation treatments, robotic surgery and new drugs. These advances sound like greater strides have been made. However most of these approved advances are of limited benefit to prostate cancer patients and still have about the same amount of long term side effects. Compared to other technologies, computers, communications, electronics, aviation, etc, cancer treatment approved advances have been dismal. QOL (quality of life) issues have not been adequately addressed. Profit sometimes outweighs QOL.

Prostate Radiotherapy (EBRT-external beam radiation therapy) for cancer treatment. New technology consists of: IMRT, SBRT, IGRT, VMAT, TrueBeam, Cyberknife, etc. This newer, faster, more accurate and easer to setup radiation equipment is of much benefit for doctors, staff and a good selling point to patient’s. However as far as reducing long term side effects, only small gains have been made with the newer radiotherapy equipment. A patient should be skeptical if exaggerated claims are made about reduced long term side effects, especially fatigue and ED rates. About 25% of radiotherapy patients can expect an alarming temporary “bounce” (spike) in the PSA value after treatment. Patients should inquire as to the treatment plan: Gy dose and fractions, margins, testicular dose, constraints and age of radiotherapy equipment to insure excessive radiation exposure treatment is not given that can result in additional side effects. Patients should be aware that pelvic shaving, permanent tattoo markers, fiducial marker (small seeds) are sometimes placed in the prostate, MRI, CT scan, photographs, catheters and other procedures may or may not a be required. Radiotherapy can also occasionally result in secondary cancers and damage to “organs at risk” (organs close to the prostate). Radiation has high probability of sexual dysfunction and fatigue. ED rates estimated at 35% to 75% or higher, 93% at 15 years. Sometimes radiation can also cause bowel and urinary problems. A 5 day SBRT radiation treatment is now commonly available with about the same results and side effects as a 9 week radiation treatment. A doctor with a multimillion dollar lease and maintenance agreement on radiotherapy, CT scan and MRI equipment and a large staff may or may not be influenced by his or her financial obligations when deciding to recommend over testing and treatment.

Often prostate radiotherapy (EBRT) can result in a 5% to 30% temporary or permanent drop in testosterone levels, excluding hormone therapy. This drop is determined by the testicular radiation dose (treatment equipment and planning). A below normal drop in testosterone can result in increased fatigue, depression, sexual dysfunction and other symptoms.

It seems all of the best treatments for prostate cancer have not been approved and most are only available outside the USA. Treatment options outside the country or under development are HIFU, Laser, Hyperthermia, Boron Neutron capture therapy and orphan drugs, just to name some. Focal Laser Ablation is a good option with fewer side effects however it is not widely available in the USA and sometimes not practical.

Any cancer patient (man or woman) who are being offered chemotherapy should be particularly cautious. Chemotherapy can be extremely toxic and sometimes deadly. Without genomic testing or proof of the effectiveness of the specific drug being used on the exact cancer type being treated, chemotherapy can often be more toxic to the patient then to the cancer. Chemotherapy may be extremely expensive, profitable for some doctors (if dispensed by the doctor and not by a third party) and can be misused or overused, sometimes for profit. A doctor may purchase a quantity of chemo drugs for $10,000 and charge a patient (insurance) $20,000. What is the motive for some doctors to perform Genomic testing and giving a patient a different and more effective treatment at an unknown profit versus a guaranteed $10,000 profit with a probable worthless and harmful treatment? This is a well documented and common practice.

When a doctor, rich, famous or influential person becomes ill often the testing and treatment are more thorough, advanced and beneficial. If you are an average or uninformed patient you may be a prime candidate for predatory doctor offering prostate cancer testing and treatment.

Often few good choices often exist for treatment. A prostate cancer patient treatment choice often ends up being the least worst choice or the choice with the side effects a patient thinks he can tolerate. Patients can sometimes be mislead about the expected side effects and results of the treatment being offered. The risk of chronic fatigue and depression is often never disclosed.

Long term care consists of regular PSA testing for years. Long term care for side effects is often lacking or exploitive or ineffective. Often complaints of side effects are disregarded by nurses, doctors and sometimes referred out to other doctors. The patient is sometimes left to figure out what to do about his side effects with the resources available to him. Long term side effects often consist of fatigue, bowel or urinary problems, sexual dysfunction, depression and other symptoms. Patients with complaints of chronic fatigue are often told to exercise, get plenty of sleep, pace yours self and eat a healthy diet; this advice is of limited help for chronic fatigue. Often treatments for long term side effects are embarrassing, degrading, unavailable, nonexistent, costly, not effective, not offered or bothersome. Prostate cancer treatment often results in fatigue, depression, isolation and sometimes suicide. Billions of dollars are profited from ED drug and other ED products, catheters, pads and diapers, drugs for depression or pain or insomnia or incontinence, additional treatments and surgeries for side effects. Also treatments for the multiple and bizarre side effects from hormone ADT therapy (chemical castration) is sometimes required.

Men, ageing and elder abuse: If any man lives long enough it is very likely he will have a prostate problem, low testosterones or some form of sexual dysfunction. In my opinion modern medicine often has been exploitive, abusive and has provided substandard care for older men in general due to all of the explanation given in this text. I believe much of the attitudes toward older Americans need improvement and they are sometimes viewed as being subhuman and exploitable by various groups and individuals. If documented cases of unnecessary surgery and radiotherapy or blind biopsies on children by doctors for profit were released, the vast majority of Americans would be outraged and this practice would quickly end. However for older men it dose not seems to be of great concern! As defined by some or all state laws, exploitation of elderly men by overprescribing treatment for profit is a crime or an offence of various guidelines and regulations. It is extremely unlikely any doctor will ever be prosecuted or have a medical license suspended for this common and extensively documented abuse or crime. One patient after recovering from a brain injury testified that he was repeatedly abused, slapped and hit, forced to drink boiling hot tea by multiple caregivers and sexually assaulted by one female caregiver. It is well documented that all forms abuse do occur to the aged and disabled in nursing homes and other facilities including, neglect, theft, starvation, torture, harassment, sexual assault, etc. I personally know of an elderly lady that is living in an expensive assisted living home that has had all of her possessions (radio, clothes, underwear, shoes) stolen and replaced by her family several times including the sheets off of her bed, even after the sheets where marked with her name using a larger permanent marker pen.

Depression in prostate cancer patients is common, about 27% at 5 years (per some studies) and for advanced prostate cancer patient’s depression is even higher. Prostate cancer patients are at an increased risk of suicide.

Almost all prostate cancer treatments usually result a high percentage of erectile dysfunction. Loss of libido estimated at about 45%. Excluding hormone therapy, lower libido is almost never disclosed as a treatment side effect and sometimes it is completely denied as a problem. Blind biopsies can sometimes or often cause temporary or permanent ED. Often claims of prompt effective treatment for ED or other side effects if they occur after treatment are often misleading. Statistics for ED percentages from treatment are usually quoted after treatment with Viagra, Muse or other ED treatments, therefore most statistics are very misleading. ED rated at 5 years may be as high as 50% to 80% or higher for most treatments. ED rated at 15 years may be as high as 90% or higher for most treatments. For cryotherapy, ED rates are extremely high. The cost for ED drugs like Levitra, Cialis, Viagra and Muse are deliberately kept very expensive by drug companies, about $10 to $45 per 1 pill. At these prices Lilly could consider including the bathtubs featured in its advertisements for Cialis. The cost of a 30 day supply of Cialis is usually well over $300 and the cost of an inexpensive bathtub is about $200. Many insurance companies will not pay for ED drugs or treatment. The patent for Viagra should have already expired in the USA. Less expensive generic drugs are usually unavailable in the US. Viagra should have already become available in a generic (in the USA) form for about $1 to $2 a pill. This is further exploitation by the drug companies of men in general. Men are also exploited by counterfeit mail order ED drug sales. ED drugs are not always effective and may have side effects. ED treatments can also be embarrassing, not offered, not practical, painful, expensive/not covered by insurance. Men will often not seek treatment because or these reasons.

The numbers game (more exaggerations)-: A doctor (and literature) may state patients chances of ED is about 35% with EBRT radiotherapy (or some other treatment). A patient may think, 35% is not too bad and if I do get ED I can always take Viagra. What a doctor may not tell a patient is that the ED rate is 35% at 2 years for a patient under 65 years old and with an ED drug treatment option. For a patient at 3 years, over 65 and no ED drugs the ED rate may be about 75% or higher, after age 70 your chances of ED is about 85%. Obviously, a man is more likely to refuse treatment at a 75% ED rate verses a 35% ED rate. Some side effects may not be disclosed at all. If side effects (low libido, chronic fatigue, depression, increased suicide risk, etc) are not disclosed, no percentages will usually need to be quoted. Results are often worse for a surgery option, the main difference in ED results between surgery and radiotherapy is; with surgery ED will start out bad and may or may not get better with time, however with radiotherapy ED will get worse over time. With both treatments together or with ADT hormones also you’re in real trouble with ED percentages. Cure rates are often quoted at the 5 years mark for most treatments. 5 years is not a magic number, you can have a treatment failure before or after 5 years. A cure rate for a treatment at 5 years may be quoted at 85%; however the cure rate at 7 to 10 years may be only 70% and 50%. Always ask what is the “biochemical recurrence” (AKA rising PSA or treatment failure) rate for well beyond 5 years with your computer software simulation. Ask your urologist or radiation oncologist for a 10-year cure Rate. If the physician is unable to provide one, consider finding another doctor. Studies and clinical trials results, side effects percentage claims, etc can be biased. Watch out for terms like “age adjusted” or ambiguous or excluded facts as given in the above examples. I have read and have been given some extremely exaggerated claims (mostly lies) concerning cure rated, side effects, etc.

In conclusion: Prostate cancer patients are sometimes elderly and exploited for profit (per documented studies). A blind biopsy is unsafe and newer test methods should be used. The treatments offered have horrible side effects. Some doctors are treating patients with low risk cancer or advanced age when monitoring is often a better option. Patience with low risk cancer or advanced age should often be offered “watchful waiting” or “active surveillance” instead of treatment. Aftercare for long term side effects is frequently ineffective, expensive, not offered, degrading or nonexistent. Prostate cancer patients are seldom told about chronic fatigue and the true risk of side effects are usually understated. Modern medicine often fails and victimizes prostate cancer patients.

If a patient has intermediate or high risk prostate cancer and dose not have advanced age he may need treatment. He should have genomic testing and look into other advanced treatments if available and genomic testing. Also he should try and avoid hormone therapy if possible because of the multiple side effects especially if the cancer is organ confined. If laser or other advanced treatments are not available a 5 day SBRT radiation treatment may be considered (In my opinion, it could be the best of the bad choices). SBRT seems to be fast, least invasive or traumatic. ED and fatigue is still a high long term risk. Radiation with hormone therapy has a higher risk of ED and long term fatigue. However, I now believe often prostate cancer testing and treatment could be a mistake in most men.

The short version of my story: I was referred to an urologist by my family doctor after a high PSA test. I will refer to the urologist as Doctor “A”; he used old testing technology (18 core blind biopsies), his nurse seemed to have a mental defect exhibiting arrogant, rude, strange and abusive behavior and was intent on inflicting psychological harm to me. Shortly after my Dr. “A” visits ended, his nurse was no longer employed at his office and no person in that office would refer to her employment or her existence. I now believe this nurse was high because of drug abuse being common among nurses (the easy access to drugs). I was diagnosed with prostate cancer by Dr. “A”. I refused his surgery and hormone therapy recommendation because of the eminent side effects and his unprofessional nurse behavior, so Dr. “A” referred me to Dr. “T”. Dr. “T” was outside of my insurance network; however his office manager stated she was willing to work with my insurance, offered me a doctor consultation and would accept any insurance payment as a full payment. When I arrived in his office the waiting room was empty. He also had a large staff. Dr. “T” used older conventional technology, offered me overtreatment, hormone therapy, unnecessary procedures and testes. One week after my consultation with Dr. “T” I received an $850 bill for the consultation, in conflict with what was agreed upon with his office manager. After a recommendation from a friend, I called Clinic “O” and met with the nurse. She offered me conventional treatments with a verbal guarantee of “no long term side effects”. However this nurse could not answer any of my basic questions, lacked any credibility and sounded like a used car salesmen. Most of these office visits caused me multiple problems with offices workers processing paperwork for tests, insurance forms and billing, etc. Two of these doctors offered me an unnecessary bone scan. Two of these doctors recommended unnecessary hormone therapy (ADT Therapy) for my organ confined cancer. After I absolutely and utterly refused hormone therapy, both doctors admitted it probably would not help me in my final outcome because of the computer estimate run on me with my PSA, biopsy report, etc. Having no advance treatments (laser, etc) available to me at that time, I decided on SBRT treatment with Dr. “K”, he could answer my questions and had new equipment. Before my treatment could start I was referred to “W” lab for an MRI. “W” lab had a trainee assisting and it took over 2 hours to complete my MRI. 2 days later after receiving a copy of my MRI report, I examined the MRI report; it had my name and some other patient history information. I wasted 2 more days verifying it was the correct MRI of me and not some other prostate patient MRI before my treatment could start. I did receive treatment from Dr. “K”. I did have a relatively fast and completely noninvasive treatment (SBRT), resulting in months of fatigue, a large PSA bounce 18 mothers later and some other short term side effects. At this time I am doing okay, however I’m not sure what the future will bring? I also no longer trust modern medicine, doctors, nurses, etc. Modern medicine seems to be more of a gamble then a science. I have wasted hundreds of hours and thousands of dollars. I feel modern medicine has abused and failed me due to the lack of guidelines and regulation, still approved obsolete technology, better unapproved treatments, exploitation, greed, apathy and incompetence. Hindsight is 20/20. I was never offered Genomic testing. I also believe I should have had no PSA testing or treatment. If I could do it over again, I would also consider no PSA testing and treatment or traveling for advanced treatments from a competent provider if practical and available. I believe if I did take the two doctors recommendations and received unnecessary hormone therapy in addition to the radiotherapy my quality of life (QOL) would have been severely impacted for years or permanently and could possibly have resulting in my early death. I did seem to have a lot of bad luck in picking providers or is this just the new standard in medical care?

“Do no harm”, unless you can make a lot of money and get away with it: I was harmed physically and verbally by Dr. “A” 18 core blind biopsy and verbally abused by his nurse. I was potentially exploited and financially harmed ($850) by Dr. “T” and offered unnecessary testing and overtreatment. Clinic “O” nurse attempted to misinform and deceive me about the treatment outcome of “no long term side effects”. I was harmed by “W” lab by mistakes and incompetence. I did also have numerous other billing and paperwork problems probably due to mistakes and apathy. A few of the office staff were incapable of completing some very simple tasks like filling out lab work request or insurance forms. At least 40% (probably substantially more, 40% to 60%) of the health care workers I came into contact with did or attempted to do some form of harm to me or provide substandard care: attempted excessive testing and treatment, mistakes, billing overcharges, blind biopsy, false statements, deception, misinformation, apathy and abusive behavior¬¬¬, as explained in this text. I have also observed several medical facilities do not require workers to wear name tags and when asked for a name most will give a first name only; this may also be a factor in health care workers not acting in an ethical manner. It seems that this prostate cancer nightmare maze was intended for maximum physical, psychological, financial harm and to be of questionable benefit. My prostate cancer experience has been one of the worst events that has happened to me in my lifetime and I specifically blame modern medicine for not protecting patients from predatory doctors, substandard technology and a lack of regulations that would protect patients.

My treatment choice: In my opinion, I feel LDR Brachytherapy and hormone therapy (AKA chemical castration) seemed to be completely degrading, disturbing and bizarre. Hormone therapy would not have been an effective treatment for me. Surgery and Brachytherapy are to invasive. Surgery has an imminent danger of incontinence and ED. A 9 week EBRT radiotherapy was just to long and laborious. Because castration (orchiectomy), ADT hormone therapy (chemical castration), LDR Brachytherapy and blind biopsies are what I consider Frankenstein medicine (strange, bizarre, brutal, twisted, degrading or a perverted nightmare) I would avoid all of them. Unfortunately, I was deceived and misguided into having a blind biopsy. I do not believe other conventional treatments like radiotherapy are good or great choices either, just not as bad and acceptable at that time for me. The choice I made was a 5 day SBRT radiotherapy. A 5 day SBRT also has numerous drawbacks and side effects, about the same as a 9 week EBRT radiotherapy. I also had no advanced treatment options available to me. As I have stated above, If I could do it over again I would also consider either no PSA testing and treatment or traveling for advanced treatments from a competent provider if practical and available. I am now sure I made the wrong choice by receiving a conventional treatment. With prostate cancer, the testing or treatment is often worse then the disease. I am not implying anyone should make the same choices as I did. I am only giving the motives for my decisions. I was also the victim of profit motivated and substandard providers. 3 years later I now believe my prostate cancer testing and treatment accelerated my ageing (through the stress, testing, treatments and physically from the radiation). Per the new SBRT studies and my 4+3 Gleason score, I now have about a 50% chance of a treatment failure in 8 to 10 years. My previous long term cure rate was originally quoted at 85% before my treatment started. I am now sure prostate cancer testing and treatment is all smoke and mirrors. When asked: “How did you live so long?” A 99 year old woman stated “stay away from doctors and don’t take anything they prescribe for you”. With some exceptions I now believe this to be mostly true.

Always protect yourself: It should not be up to a patient to protect himself or herself from harm from doctors, however the new standard in medical care now seems to be substandard. Do not let the sterile, friendly and professional environment of a doctor’s office detour you from protecting yourself from overtreatment or any unnecessary life changing tests and treatments. If you are concerned about misuse or privacy issues, refuse to fill out EPIC questioners and limit the information given to relevant information only. If you have a high PSA or prostate cancer, educate yourself. A patient should be extremely skeptical if exaggerated claims are made about minimal long term side effects from conventional treatments or blind biopsies. Bring someone educated or astute with you to your consultations and appointments. Insist on Genomic testing if you have prostate cancer. Avoid doctors that are mostly profit motivated. Do not submit to a prostate blind biopsy if other options are available. Get a second or third opinion if you are being offered treatment with low risk prostate cancer. Learn about all your treatment options, testing and side effects. Verify everything you are told. Under the HIPAA law you are entitle to a copy of all your medical records and bills. Always ask the name of the person assisting you. If they refuse the request for a name leave immediately (you may or may not be in extreme danger). Be very cautious if you are ever refused a copy of your records; demand a copy of your records and a reason for any denial and seek other advice. Get a copy and keep a file of your test results, biopsy report-Gleason score, PSA, MRI report, treatment plan, bills, insurance payouts, etc. Carefully monitor your PSA. Expect a temporary increase (for weeks or months) in PSA after some procedures. Verify the accuracy of paperwork. If treatment is necessary talk to your doctor in advance about side effect management, chronic fatigue, ED, etc. Doctors that provide treatments often have computer software to predict the outcome using test results and different treatment options. Ask to see your computer predicted cure rate outcome with your treatment options if available. This may give you some insight to your options, cure rate and also to avoid overtreatment. Always ask what is the “biochemical recurrence” (AKA rising PSA or treatment failure) rate for well beyond 5 years. For help contact a good prostate cancer support group without a conflict of interest. A wise man once told me “you need to learn to think like your doctors and nurses (or other providers)”. What are the motives of your providers, place them in order that you observe at your doctors office: to profit, to cure, to get high on the backroom drug supply, to do less work, to take an extra long lunch or get off work early, to help people, to cover up their incompetents, etc? This exercise may give you some insight into the care you may receive.

A medical holocaust: Multiple studies have verified more deaths caused from prostate cancer testing and treatment then from prostate cancer itself. Medical mistakes are the third leading cause of deaths in the USA (over 251,000 deaths a year, over one million deaths in 4 years) more then suicide, firearms and motor vehicle accidents combined. These statistics do not include people that have had there lives destroyed by modern medicine or a reduction in QOL (quality of life).

Strict guidelines for prostate cancer testing and treatment need to be created and enforced because of the extensive and documented abuses of prostate cancer patients: 1. Blind biopsies should be banned. 2. Strict standards and gridlines for testing and treatment need to be created. 3. Full mandatory industry standard disclosure forms need to be created for tests and treatment to include realistic risk factor disclosure. 4. Newer testing and treatments need to be created and approved. 5. Dignity, privacy and confidentiality need to be standardized and enforced in addition to the HIPAA laws. 6. Aftercare needs to be available, standardized and regulated. 7. The cost for drugs needs to be regulated to end financial exploitation by drug companies. 8. Medical workers should be identifiable and be required to wear name tags with first, last names and job title. 9. A new standard “Ethical Code of Conduct” needs to be created and enforced to end patient exploitation and abuse. 10. Genomic or genetic testing should be required before any patient is sent for treatment, to avoid overtreatment and insure the correct treatment. 11. A standardized education book or PDF document needs to be created and distributed to all high PSA and prostate cancer patients.

It is unlikely any of the above recommendations will be implemented unless prostate cancer affected a larger percent of the population or enough prominent people are affected. Prostate cancer patients must protect themselves as the only alternative!

Clarification: The above text may probably anger and upset some people for various reasons. The intent of this document is not to imply all doctors are dishonest or to condemn all medical providers. The intent is to educate men and prostate cancer patients of the consequences and dangers that may await them so they can take appropriate action and to inform patients of real world, typical or worst case scenarios. I have also tried to include most scenarios a prostate cancer patient should be cautious of. Would some health care providers harm a patient for profit or by accident or some other reason? Yes, absolutely! We just don’t know who or what percent would. Shockingly, for me it was will over 40% (probably 50% to 60%) that intended to do me some form of harm or provided substandard care as explained in my story. . I have also had excellent doctors and nurses, however this may not protect you from the bad ones. Are some other doctors and nurses exceptional? Yes! Differences in opinion, variations in semantics do not invalidate this document or its intent. The information in this document is a sum of my experience, other patient’s experiences and hundreds of videos, documents, books, conversations, clinical trial, blogs, studies, articles, etc.

Disclaimer: I have no conflict of interest. I do not represent any support group or other organizations. I am not a doctor. I do not prevent, treat, diagnose, cure or advise on medical matters. The information above is for educational purposes only. If you need treatment or medical advice, consult a competent and trustworthy medical doctor.

Anyone may copy, email or distribute this document without changing or modifying it.

I have been extensively criticized by some for creating this document and its blunt content. In order to insure my privacy and avoid any potential reprisals, further abuse or exploitation, I will remain Anonymous.

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