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To Screen Or Not To Screen: The Prostate Cancer Dilemma

by Dr. Len October 07, 2011

To screen or not to screen for prostate cancer, that is the question. Or is it?

 

A report from the venerable United States Preventive Services Task Force (USPSTF) made it to the media yesterday--a bit ahead of schedule--and it not only says we aren't certain whether a man should get a PSA test to find prostate cancer early, it came flat out and said, effectively, "Don't do it!"

 

Now that is a recommendation that is going to create a good deal of discussion, I would think.

 

Whether PSA testing to find prostate cancer early really saves lives is not certain. The test has been around for over two decades, but it wasn't until recently that there were any scientific studies that could provide evidence whether or not the test actually worked. And those two studies produced conflicting results, or so it seemed.

 

One study done in several European countries found that PSA screening reduced deaths from prostate cancer by about 20%. Another study done in the United States concluded that PSA screening did no such thing. In fact, in the US study, the deaths from prostate cancer were greater during the period of the study in men who were screened vs. those who were not, but that difference was not found to be statistically significant.

 

Basically, what has happened is that the Task Force reviewed all of the evidence as to whether or not PSA screening decreased death rates from prostate cancer, and whether or not the harms from early diagnosis and treatment outweighed the benefits.

 

In reviewing the available studies, they found studies that tried to answer the question, but didn't find any that were really well done. So they had to rely on a lesser level of evidence, and among that evidence were the two studies noted above.

 

In the European study, they pointed out that for ALL of the men included in the study, ages 50-74, there was no reduction in deaths in the group with PSA testing. They also pointed out that the European study was in fact a "compilation" of trials in several centers in several countries, and that the frequency of PSA testing differed considerably from center to center (every 2-7 years, not every year as is commonly done in the United States).

 

The USPSTF researchers also pointed out that the group where the reduced death rates were found was in fact a "select" group of men ages 55-69. Furthermore, not all men in that study were treated equally: men who were in the "PSA testing arm" were treated in academic centers, where they would have arguably received better care, compared to the untested control group who were treated in community hospitals.

 

Another wrinkle was highlighted by the researchers who pointed out that one of the Swedish centers that participated in the trial had exceptionally good results (in fact the only center in the study that had such great results). Take that center out of the analysis, and voila! the benefits of screening in the European study miraculously vanishes.

 

Then there was the United States study, were many of the men in the "untested" control arm had PSA tests anyway, thus making the results of "no benefit" less than clear cut.

 

I could go on, but I think you can begin to understand the dilemmas all of us have faced in trying to figure out whether or not PSA testing really works. And let's not ignore the question of what happens to men after they receive treatment for their prostate cancer, problems that are not insignificant such as incontinence of urine, difficulty with bowel movements, impotence and more. These are not minor issues.

 

So here is a test that has strong advocates, not the least of whom are the truly well-meaning men and their loved ones, friends and colleagues who truly believe that PSA testing saved their lives. And not a few of those men are in positions of influence, including a number of Congressmen and Senators, senior executives, celebrities, you name it. They were told that PSA testing saved their lives and I would expect they would take that advice to heart. Hear it often enough, and you believe it.

 

But just saying something often enough, loud enough and clear enough does not make it so. Just ask the women who took all those hormones for all those years, and all those doctors who thought they were doing the right thing for their patients by prescribing those medications. They too thought hormones were good for their health, until the evidence proved it wasn't so. (Hormone therapy remains a useful treatment, but only with a clear understanding of the risks and benefits of those treatments.)

 

So, now we find ourselves on the horns of a dilemma. The Task Force is on record as recommending that men NOT get PSA testing. They conclude there is no real proof of benefit, and real proof of harms. Too many men go through too many treatments with too many long -lasting complications without a clear expectation that it will save their lives.

 

That's pretty radical, and is certain to raise a firestorm of criticism among those who believe that PSA testing saves lives.

 

The American Cancer Society went through the same evidence a couple of years ago and had the same discussions. We elected to say to men that we did not know whether or not PSA testing saved lives, but thought the best approach was for men and their health professionals to have a clear discussion, outlining the benefits and risks before embarking on a program of PSA testing. And that remains our recommendation today.

 

But I will say that even then, the evidence of benefit from PSA screening was certainly not overwhelming, if it existed at all. We knew then about the issues with the United States trial; there were whispers about some problems with the European study that are now more clearly discussed in the Task Force report. But the bottom line remains for both organizations that the evidence is not firm that the test makes a real difference.

 

After all this, you know what really gets me upset?

 

We have invested over 20 years of belief that PSA testing works. Catch it early, treat it early, and get it out. Save a life. That's the mantra many of us--including me, as a practicing physician--believed. And here we are all of these years later, and we don't know for sure. That is not an acceptable situation. Plain and simple, we have not done our homework to prove our point. And the chickens are coming home to roost.

 

Unfortunately, those "chickens" are men like me who dutifully get our blood tested every year. We have been poked and probed, we have been operated on by doctors and robots, we have been radiated with fancy machines, we have spent literally billions of dollars. And what do we have? A mess of false hope?

 

Back in the early part of this decade, researchers came to the conclusion that although there were some benefits to hormone therapies for post-menopausal women, there were more harms that outweighed their routine use. Almost a decade later, there has been a significant decline in hormone usage, we are more aware of the risks, we counsel our patients carefully about the use of these medicines, and we recommend the lowest dose for the shortest period of time.

 

Now we are about to face similar issues with prostate cancer screening. We will argue, we will refute the other persons science, yet I suspect we will come to an understanding that just because experts, doctors and grateful patients and their families say it often enough and loud enough does not make it so.

 

As someone reminded me recently, anecdote is not a form of evidence. And for PSA screening, unfortunately, according to the Preventive Services Task Force, the evidence just isn't there.

 

It's always hard to learn that the emperor in fact has no clothes. The sad reality, however, is that this debate is not about a fairly tale. It's real life, my friends. And people have been hurt, and doctors have been deceived. At least, that's what the Task Force is saying.

 

Maybe it's time to listen to evidence instead of hope. Sometimes that's hard to do.

Comments

10/9/2011 12:28:18 AM #

Stanford J Carter

October 8, 2011

To: Dr. Len Lichtenfeld

Dear Dr. Lichtenfeld:

In hindsight Brachytherapy, probably the best procedure, may have been unnecessary.  

Local Family Practice physician in Louisiana referred a urologist, whose work was not perceived as good because long time patients of his wore diapers and catheters  months after radical prostatectomy.  

Instead treatment was sought in a Houston, Texas hospital 2½ hours from my home in Louisiana.  After checking in, procedures included a required urine test, though urination had been done 30 minutes prior. Pressure of urine was minimal.  PSA was around 6.5 or 7

A biopsy was scheduled and done.  During the interview regarding biopsy, radical prostatectomy was explained.  On denying radical prostatectomy doctor jumped up and bursed from room.

Referral was made to radiation department where radiation procedure was explained, namely that several injections costing $3,000 each would be necessary for the seven week procedure.  A vile was provided for injecting prior to the costly medications.

Confidence was lost in this hospital and further research suggested a noted hospital in Los Angeles.  A cousin who is a MD in LA was called and told I would like to meet the doctor from my research.  He laughed and said that’s my doctor, who had done a Brachytherapy procedure for him.

Arrangements were made and a Brachytherapy procedure was done in about 45 minutes, 2 hours in recovery, and left for my daughter’s house.  Operating doctor told me there was no enlarged prostate.  Next day included removal of  catheter and examination by neurologist.   That was five years ago.

During that time there were untold issues of incontinence of urine, difficulty with bowel movements, impotence and more.

A niece of my wife visited us and when asked where she worked she said MD Anderson Hospital and proceeded to tell me about the hospital.  DARN!!!  Had I known that I could have done my prostate procedure in Houston.  

Upon learning of MD Anderson files were transferred from Los Angeles to MD Anderson where checkups were done every six months for three years and annually for the last two years with PSA readings 0.02 and told that it’s undetectable.  

First doctor in Houston lost his job under what appeared to be specious circumstances.  In addition the Los Angeles hospital relied on information from Texas hospital without doing an independent test.  The bad taste is that too many prostate operations seem to be done with prolonged side effects and without proper cause.

Stanford J Carter

10/15/2011 9:31:56 AM #

Tim Bartik

Given your discussion of the evidence, it would seem to me that you should recommend that the Task Force modify its recommendation of a "D" grade for prostate cancer screening to a "C" grade. As I'm sure you know, a D grade means the Task Force has concluded that there is moderate certainly that harms outweigh benefits, and that therefore this screening should not be done. The C grade means that although the screening should not be routinely done, decisions to do screening should be made on an individual basis.

I simply don't see how the Task Force can reasonably conclude, based on the available evidence, that there is moderate certainty that the harms of screening outweigh benefits, at least from the perspective of many men.

I think if one delves further into the European study, which on the whole I think is a better test of screening vs. no screening than the U.S. study, the possible benefits of screening seem to increase. As you probably know, although the European study cited a NNT (number needed to treat) of 48 to 1 death averted, and a 20% reduction in prostate cancer deaths in the screening group, these figures are averages in the screening group with an average follow-up of 9 years after the experiment was begun. You are probably aware that more recent analyses of the European data suggest that after 12 years, the relative benefits of screening have increased, to a 50% plus reduction in prostate cancer mortality and a NNT of 18.

An NNT means the following: for prostate cancers detected by screening, there is a 5% probability that this diagnosis will reduce your chances of dying from prostate cancer by 12 years after the screening was begun. (The time interval from diagnosis and treatment would be shorter.) Men have to tradeoff this risk against what the Task Force identified as a 30% added risk of serious side-effects of treatment.

Although it is true that the risks of side effects exceed the probability of the treatment being life-saving, the choice here is by no means obvious. There are probably men who would say, "I'd rather just take my chances to avoid the potential side-effects of treatment". There are other men who will say "I'd much rather be alive and have the side-effects than be dead, so I'll take my chances with the side-effects, while trying to minimize them by finding the best surgeon possible.."

In any event, I don't see how the evidence justifies "moderate certainty" that the harms outweigh the benefits of treatment. This is in part a question of science. It also is a question of relative values, about which men are by no means agreed.      

Tim Bartik

10/15/2011 11:15:31 AM #

Len Lichtenfeld

Tim, you make an excellent point and certainly is something we are going to consider as we prepare our comments for the Task Force. It is not realistic for anyone to expect that PSA testing is going to disappear over night, but I do think that over time the discussion is going to become more balanced. It has to, based on the evidence.

Having said that, I will share with you and others that after having listened to the Task Force conference call yesterday afternoon, it is hard to refute what the task force is saying. That led me to reread the Task Force draft recommendations this morning, and again I came away with an overwhelming sense that the Task Force has very carefully teased apart the arguments in favor of PSA screening and shown them to be without reasonable foundation. But I suspect that most people aren't reading what they had to say. They are responding to the media, and the simple "Don't do it" recommendation.

Then, I read a tweet where a urologist wrote an opinion piece that he was going to continue recommending PSA, basically because he thinks it works.

That is the crux of the issue: the evidence simply isn't there--no matter how optimistic one might want to be that PSA testing works--and those who have their own personal opinions are offering just that: opinions. As I have said above, it is very hard to look at the evidence when everyone has so much hope. But we have to be at least open to the thought that hope is causing harm. That may be a large step for some, but we have to take that step.

Thanks

Len

Len Lichtenfeld

10/15/2011 11:53:43 AM #

Tim Bartik

Dr. Lichtenfeld:


Thank you for your response to my comment.

I would be very curious as to what you found particularly persuasive in this conference call. I also would be curious as to what you found particularly persuasive in the Task Force's draft recommendations.

My own reading of the Task Force's draft recommendations does not find a grade of D to be consistent with either some of the text of the recommendation or with the Task Force's own review of  the evidence. In the text, they mentioned that some men may wish to do testing because they perceive the possible small benefits to be worth the side-effects. This is more consistent with a C recommendation. And their own review of the research evidence seems consistent with the notion that the European study, overall, probably is the best study, although even it has its flaws.

I also think that the Task Force's review of the evidence under-values what some recent analyses have found about the long-run effects implied by the European study. I simply don't see how a 5% reduced probability of death after 12 years for each man diagnosed with prostate cancer due to screening can be regarded as a "small effect".

I would be curious what you would think about the views of Dr. Richard Hoffman, recently posted at the Health News Review blog. Dr. Hoffman also seems to find the Task Force's recommendation and review to be flawed.
www.healthnewsreview.org/.../...cer-screening.html

Sincerely,

Tim Bartik

Tim Bartik

10/15/2011 3:42:25 PM #

Derek Wilson

Thank you for this discussion.  I think we need some time to express our feelings over this news.

I feel hopelessness and despair over the prostate cancer screening fiasco whose magnitude has become fully revealed these last few weeks.  And I feel tremendous anger at the medical establishment and its government counterparts, at allowing it to develop to this extent.  I know I am not alone.

And it surely is a fiasco.  If reports are correct, large numbers of men have received unnecessary treatment with devastating side effects in order to achieve the reductions in deaths we have seen over the last twenty years.  And now that the harms are fully revealed, the divided medical community’s suggestions are to either continue in this fashion or return to the dark days when men went to their doctors with diffuse lower back pain only to find out they had inoperable metastatic prostate cancer that would kill them in short order, leaving their families crushed and heart broken.

Your own Dr. Otis Brawley describes the situation with prostate cancer as “…a major public health problem”.  Yet it does not appear to be treated so by those in authority.  

Occurring during National Breast Cancer Awareness month, as this news did, men cannot help but compare situation between the two cancers, both with similar incidence and death statistics, and conclude the medical establishment and their counterparts in government, and our government representatives, are treating them very shabbily.  It may be short sighted and unfair, an example of the “disease Olympics” Dr. Brawley decries, but I find it hard to blame them.  They compare research funding and discover prostate cancer research funding is half or less in every instance.  They compare treatment under the Affordable Care and Patient Protection Act, now being implemented, and they see prostate cancer will be subject to the most severe cost-cutting scrutiny.  They compare treatment in the popular culture where breast cancer awareness receives overwhelming support and prostate cancer is relegated to the status of an old man’s disease that is only to be expected and can be ignored.

If those in medicine, government, or advocacy can defend their actions over the last twenty or thirty years, I suggest they start.  From what I have garnered in reading the discussions men have generated around this issue, no one in medicine, government, or advocacy has any further credibility to rely upon.

Derek Wilson

10/17/2011 2:16:26 AM #

Kurt Frantz MD

I think the USPSTF has done a disservice to the public and overstepped its own finding in this new recommendation and think its prior statement was the correct approach.  In reviewing both the studies, and the studies related to treatment and outcomes of various groups of prostate cancer patients I cannot help but believe that a  study of 9 or 10 years is insufficient to determine the validity of PSA testing.  Prostate cancer is a slow growing tumor and our current treatment regimens give even many men with high grade tumors a 10-15 year window of survival. The most likely group to benefit from PSA testing are those 50-69 yr old healthy men with intermediate grade tumors found at an early premetastatic stage where treatment can be curative.  Those with low grade and indolent disease will likely need only follow up surveillance with no treatment and those with high grade lesions will likely die of their disease but with lengthening of their survival.  The lowered death rate overall will be small but real, I would surmise, and will take a 20 year study to determine a more valid measurement of the effect of screening with a PSA.  If we study colonoscopy for a three year period do you think we would find a survival benefit? NO. It took a 10 year study by Kaiser to really answer the question of benefit.   Prostate screening effect is lower as we are dealing with a much smaller subset of patients who have cancer that would benefit, it is a slower growing tumor with a longer survival with our without treatment than colon cancer, and will therefore take a much longer study to determine the effect of screening.  I agree the recommendation should be a C still and there is no new evidence to lead me to believe it should have been changed. That is my opinion on looking at the data.  We cannot ignore that it does appear early diagnosis of this subgroup has a positive survival outcome with selected therapy as based on the urologic cancer literature.  

Kurt Frantz MD

10/27/2011 4:01:05 PM #

Gregory D. Pawelski

Gary Schwitzer at HealthNewsReview mentions about The New England Journal of Medicine having four perspective pieces on the new US Preventive Services Task Force's prostate cancer screening recommendations:

www.healthnewsreview.org/.../...cer-screening.html

Gregory D. Pawelski

10/30/2011 11:21:06 PM #

dental care charlotte

Interesting article... I have always been under the impression that screenings were so important.  Thanks for sharing!

dental care charlotte

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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