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One Man at a Time — Resolving the PSA Controversy

Mary F. McNaughton-Collins, M.D., M.P.H., and Michael J. Barry, M.D.

N Engl J Med 2011; 365:1951-1953November 24, 2011

Comments and Poll open through November 30, 2011

Article

Who should decide about screening for prostate cancer: expert panels of clinicians and methodologists, primary care clinicians, specialists, or fully informed patients themselves?

The U.S. Preventive Services Task Force recently released a draft recommendation on screening for prostate cancer, designed for primary care physicians and health systems, and has opened it for public comment until November 8, 2011.1 After completing a rigorous evidence review, the task force decided to recommend against screening for prostate-specific antigen (PSA), concluding that there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. This grade D recommendation applies to healthy men of all ages, regardless of race or family history. The task force's suggestion for practice for grade D interventions is to “discourage the use of this service.”

We applaud the task force's careful evidence review and synthesis of results from five screening trials. At the time of the previous (2008) recommendation on PSA-based screening for prostate cancer, task force members had concluded that the evidence was insufficient to allow them to make a recommendation for younger men, but they recommended against screening for men 75 years of age or older. With the results of the screening trials now available, there is finally higher-quality evidence to bring to bear on the question of PSA screening. However, as noted in the task force's review of the evidence, the results of the two largest, highest-quality trials conflict, and we have described the question of screening for prostate cancer as “the controversy that refuses to die.” Will this grade D recommendation finally sound the death knell for the PSA controversy?

Although we agree with the task force's synthesis of evidence and conclusions regarding the substantial harms that can be associated with PSA-based screening and treatment of screening-detected prostate cancer, we have a different perspective on the key question of benefit. The task force points out that no trial showed a decrease in overall mortality with the use of PSA-based screening through 11 years of follow-up and that all trials showed either a small or no benefit in prostate-cancer–specific mortality. But who is to decide what constitutes a “small” benefit and whether it outweighs the potential harms?

We would argue that the European screening trial2 had fewer methodologic limitations than the U.S. trial (less contamination in the control group and less prescreening in the trial population). In addition, among men 55 to 69 years of age in the European trial, there was a significant absolute reduction in mortality related to prostate cancer of about 7 deaths per 10,000 men over a median of 9 years of follow-up. Such a reduction might be small in the eyes of some men, but larger in the eyes of others. It is also possible that a larger benefit might accrue with longer follow-up, as suggested by the Göteborg subgroup analysis in the European trial.3 However, only time can provide substantiation for that argument, and like all subgroup analyses, these data must be interpreted cautiously.

Our perspective is that this evidence of a possible small but finite benefit from the largest trial would best support a grade C recommendation for men 55 to 69 years of age. With a grade C recommendation, the task force would be recommending “against routinely providing the service” while indicating that “there may be considerations that support providing the service in an individual patient” and stipulating that “there would need to be at least moderate certainty that the net benefit is small.” The task force's suggestions for practice in the case of a grade C recommendation include the suggestion that they “offer/provide this service only if other considerations support offering or providing the service in an individual patient.”

A grade C recommendation would allow the patient to be involved in the decision to skip or choose a PSA screening test, after a discussion with a primary care provider about the magnitude of the known harms and the potential for some benefit. The patient could then provide his perspective on how he views the trade-off. Weighing the pros and cons to make a decision about PSA screening is an individual process, and different well-informed men will make different decisions. A grade D recommendation removes the patient from the equation and puts the physician in the central position of discouraging use of the test. Uncertainty in medicine is more common than we usually let on, and the way to address uncertainty is to allow patients the central position in decision making. A grade C recommendation would acknowledge that whereas the evidence shows that the harms may outweigh the benefits on a population level, some individual patients will still elect PSA screening. We do not believe that anyone but the patient should decide whether the small and uncertain benefits of PSA screening are worth it.

A grade C recommendation would come with considerable responsibility for primary care clinicians. We cannot simply pay lip service to shared decision making. The PSA test could no longer be ordered routinely, without discussion, as if the benefits clearly outweighed the harms. Perhaps in making a grade D recommendation, the task force took into consideration the dubious record of decision making for PSA testing.

There is abundant evidence that we have not engaged in shared decision making for prostate-cancer screening in the United States.4 We have been ordering PSA tests without discussion, we have been ordering them in very old men without anything to gain, we frequently discuss the pros of PSA tests and infrequently discuss the cons, and we do not routinely ask our patients for their preferences regarding PSA screening. That has to change for a grade C recommendation to be reasonable.

The American Cancer Society (ACS) recently updated its guideline for the early detection of prostate cancer,5 recommending that asymptomatic men who have at least a 10-year life expectancy be given an opportunity to make an informed decision with their health care provider about screening for prostate cancer after they receive information about the uncertainties, risks, and potential benefits associated with screening. The ACS asserts that prostate-cancer screening should not occur without an informed decision-making process. We support that recommendation and the ACS's accompanying analysis of what men need to know before making an informed decision about PSA testing and ways to make sure they know these key facts.

In addition to helping our patients make informed decisions about PSA testing, we should ensure that appropriate patients are offered the options of watchful waiting (observation and physical examination with palliative treatment of symptoms) and active surveillance (periodic monitoring with PSA tests, physical examinations, and repeated prostate biopsy with attempted curative treatment for signs of disease progression or worsening prognosis) if prostate cancer is diagnosed through PSA screening. Watchful waiting and active surveillance may help prevent the conversion of overdiagnosis to overtreatment, mitigating the harms of screening that are so accurately portrayed by the task force.

To make a grade C recommendation appropriate, we primary care clinicians must ensure there is no more routine, indiscriminate PSA screening — and no washing our hands of responsibility once the patient is referred to a specialist for prostate-cancer treatment. We owe it to our patients to provide them with the kind of guidance about this screening test that they need and deserve. That's the way to help put the controversy to rest . . . one man at a time.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMp1111894) was published on October 26, 2011, at NEJM.org.

Source Information

From Harvard Medical School and Massachusetts General Hospital — both in Boston.

References

References

  1. 1

    United States Preventive Services Task Force. Draft recommendation statement. October 2011 (http://www.uspreventiveservicestaskforce.org/draftrec3.htm).

  2. 2

    Schroder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009;360:1320-1328
    Full Text | Web of Science | Medline

  3. 3

    Hugosson J, Carlsson S, Aus G, et al. Mortality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 2010;11:725-732
    CrossRef | Web of Science | Medline

  4. 4

    Hoffman RM, Couper MP, Zikmund-Fisher BJ, et al. Prostate cancer screening decisions: results from the National Survey of Medical Decisions (DECISIONS Study). Arch Intern Med 2009;169:1611-1618
    CrossRef | Web of Science | Medline

  5. 5

    Wolf AM, Wender RC, Etzioni RB, et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin 2010;60:70-98
    CrossRef | Web of Science | Medline

Citing Articles (4)

Citing Articles

  1. 1

    Schröder, Fritz H., Hugosson, Jonas, Roobol, Monique J., Tammela, Teuvo L.J., Ciatto, Stefano, Nelen, Vera, Kwiatkowski, Maciej, Lujan, Marcos, Lilja, Hans, Zappa, Marco, Denis, Louis J., Recker, Franz, Páez, Alvaro, Määttänen, Liisa, Bangma, Chris H., Aus, Gunnar, Carlsson, Sigrid, Villers, Arnauld, Rebillard, Xavier, van der Kwast, Theodorus, Kujala, Paula M., Blijenberg, Bert G., Stenman, Ulf-Hakan, Huber, Andreas, Taari, Kimmo, Hakama, Matti, Moss, Sue M., de Koning, Harry J., Auvinen, Anssi, . (2012) Prostate-Cancer Mortality at 11 Years of Follow-up. New England Journal of Medicine 366:11, 981-990
    Full Text

  2. 2

    G. Mikuz. (2012) Die Prostatabiopsie – eine unendliche Geschichte. Der Pathologe 33:2, 99-102
    CrossRef

  3. 3

    Viacheslav Iremashvili, Lisét Pelaez, Murugesan Manoharan, Mercé Jorda, Daniel L. Rosenberg, Mark S. Soloway. (2012) Pathologic Prostate Cancer Characteristics in Patients Eligible for Active Surveillance: A Head-to-Head Comparison of Contemporary Protocols. European Urology
    CrossRef

  4. 4

    Giorgio Guazzoni, Massimo Lazzeri, Luciano Nava, Giovanni Lughezzani, Alessandro Larcher, Vincenzo Scattoni, Giulio Maria Gadda, Vittorio Bini, Andrea Cestari, Nicolò Maria Buffi, Massimo Freschi, Patrizio Rigatti, Francesco Montorsi. (2011) Reply from Authors re: Andrew J. Vickers, Hans Lilja. PSA Is Dead, Long Live PSA. Eur Urol. In Press. DOI:10.1016/j.eururo.2011.11.045. European Urology
    CrossRef

Comments (48)

48 Reader's Comments

Page

Data by Profession and Location
JAMES CAVE, MBBS | Physician | Disclosure: None
NEWBURY United Kingdom
November 27, 2011

Missing the point

Just getting your prostate cancer diagnosed does not mean a doctor has saved your life, or even given you longer to live. The science in the studies simply has not shown that to be true. I am pleased that those who have had a diagnosis are glad they went through the ordeal and feel it has made a difference for them, but I worry when they go around preaching that their life has been saved by having a PSA and getting their colleagues to get one too.
So what are the alternatives to PSA you all ask?
Get on with life, spend less time in a doctor's room and more time walking and enjoying life, and if you get symptoms, go and see a doctor. You will live just as long and perhaps with all that extra exercise a little bit more.

JEANNE LENZER | Other | Disclosure: None
KINGSTON NY
November 27, 2011

Poll query linked to article improperly framed

As a journalist, I've found that many providers who believe the USPSTF Grade D recommendation, also believe in initiating a discussion with the patient by explaining the controversy, the reasons for the Grade D recommendation, and letting them decide based on that information. By shoehorning every provider who agrees with the Grade D recommendation into an option that states they would not initiate a conversation with the patient (according to the 3 poll options), NEJM introduces an element of bias, potentially forcing some providers to check off option B (support Grade C recommendation and initiate a conversation).

Ferdinand Frauscher | Physician | Disclosure: None
Austria
November 27, 2011

Do we need imaging for successful prostate cancer screening?

One of the major problems I see in the discussion to screen or not for prostate cancer, is the lack of an imaging method, which allows for detection, localisation and size and number of prostate cancer lesions. In Innsbruck we have already introduced PSA screening in 1988. The acceptance of PSA testing was good, however the approach when PSA is elevated, the next step is systematic biopsy has shown to be not effective. Systematic biopsy is an old technique with a lot of disadvantages including inaccuracy, invasiveness and no detailed information about the cancer size. Furthermore systematic biopsy has shown often to result in undergrading of prostate cancer, which may result in inadequate therapy. New imaging techniques - including contrast-enhanced US and sono-elastography - have shown the potential to detect cancer. Furthermore multiparametric MRI is also useful. In addition the combined use of US and MRI with new imaging fusion techniques is promising. Therefore I believe that imaging will play a major role in prostate cancer screening, since the current data show that imaging may allow for diagnosis of "relevant cancers", where therapy will improve patient survival.

WILLIAM FULLER | Student | Disclosure: None
BROOKLYN NY
November 27, 2011

Missing the Point

I am disheartened by several of the comments on this page that seem to miss a main point of the discussion. Even if we grant that there is some small absolute prostate cancer-specific mortality reduction associated with PSA screening, what is the cost, both financial and in terms of personal harm, associated with one death prevented by PSA screening? Those on this forum having undergone prostate biopsy will agree that it was a painful procedure, and the costs associated with it and its complications are high. How many patients will undergo this hardship and possibly suffer lasting harm in the hopes of preventing a disease that their PSA, due to its lack of specificity, does not reliably indicate that they have?

The question is not whether PSA might find cancer, but whether ordering it will be in the interests of an individual patient. If we refuse to believe the results of two controlled trials indicating that it truly isn't, we have given up any pretense of practicing evidence-based medicine. In short, just because it is the best test we have does not mean it's a good test, or that it should be used in a screening capacity for patients without a history of prostate cancer.

IAN HOLLIDAY | Other | Disclosure: None
GRAVESEND United Kingdom
November 24, 2011

A question of values?

Although a professional, I have read these comments as a patient looking for some facts before opting for biopsy following a superb PSA velocity which should be studied. Interesting as it is that the "ding dongs" a someone calls us, are arguing about research limitations and findings but there are several anecdotes of patients who are now alive because of screening, whether via DRE, PSA or biopsy. In the face of those anecdotes, I find myself saying "Regardless of the statistics, here are people - able to speak because of life saving intervention. OK, only a few but, I am minded to say I'd like to be one of those whose life is extended and who can continue to read this web site for a few more years." Maybe I am wrong but, then again, those of you who advocate patient discussion might glean something from my, maybe twisted, mind set. Alternatively, maybe someone should do some decent research on why patients have trouble deciding, rather than, again, anecdotal stuff.? Dr Siguel above seems to be the only one making sense to me, as a patient, when he says that patients need more data and more depth.

Timothy Dayton | Other | Disclosure: None
November 24, 2011

PSA Testing

The PSA testing I had done over a number years showed a gradual rise in the last 3 years until it reached > 4.0. At that point I did not have any symptom detectable by DRE. I decided to have a biopsy and was presented with cancer in several pin samples with a Gleason of 6 or 7. I decided to have surgery, I was 55. I had successful surgery and post operative testing showed a Gleason 7 and a relatively aggressive sort of cancer. I am very glad I did what I did and I am satisfied with the results so far. Had I not had the testing I am not sure how long it would have been to have a DRE indicate a problem and then what would be my choices several years further into cancer growth. Until there is a better test the PSA is the best we have even if it isn't perfect. Early detection permitted prostate removal with wide margins and with the use of nerve sparing surgery. I have had excellent results and am not worried about this problem anymore. I do get a PSA test every 6 months just to make sure it hasn't spread.

HENRY FOURCADE, MD | Physician | Disclosure: None
Blaine WA
November 23, 2011

Retired Anesthesiologist

My father had annual H&P's and was in good health until his first PSA test result returned at 79. He had external beam radiation for invasive prostate cancer followed by a complicated medical course. I would like to continue my annual PSAs & DRE, and know when my PSA is rising before it hits 79. Is someone in this free country going to tell me that is unethical?

MR ERNEST KRAUS, RPH | Other | Disclosure: None
WOODBURY NJ
November 23, 2011

My PSA <4.0

I too had increasing PSA's but never hit that magic .4.0. Digital exam found no enlargement, firmness and a small nodule. My urologist scheduled me for a biopsy with the comment " I'm sure it will be negative, but let's be sure." An evening phone call from him said that 12 of 16 biopsies were positive with Gleasons og 6/7. I opted for surgery with continuing PSA follow up. Some years later, the PSA went from <0.01 to detectable levels. Consultation with both my surgeon and the radiation oncologist came up with a diagnosis of recurence. I also found out that I'm part of the 35% that do reoccur. I opted for XRT and continue to monitor PSA. I can only speculate what would have happened had I not had the surgery; would I still be alive? Would I have mets? No one knows. I don't care about the studies, the statistics, the cost. To me, it was worth it.

JAI JOSHI, MD | Physician | Disclosure: None
LAREDO TX
November 23, 2011

Answer to Poll Question

The four articles in this issue illustrate, there is no right answer to the poll question. The seemingly easy answer is that you initiate a discussion, but that’s the wrong choice.

john williams | Other | Disclosure: None
November 23, 2011

PSA alternatives

I keep waiting for the medical "experts"to tell me what alternative tests are available for determining the presense of prostate cancer?????

GIOVANNI SALAMANO, MD | Physician - Endocrinology | Disclosure: None
VERCELLI Italy
November 06, 2011

Prostatic cancer screening: what is the most useful screening procedure?

The hypothesis that the pathogenesis of prostatic cancer is linked to an inflammatory process seems sufficiently demonstrated by both hystological and clinical evidences supporting the presence of a precancerous lesion called "Proliferative inflammatory atrophy."
Molecular genetic supports this idea demonstrating that hypermethylation of CpG island of Gluthatione Methyl Transferase (GTP1) gene, on chromosome 11q13, is the cause of reduced transcriptional and antioxidant activity of this enzyme, causing an increased genomic instability at prostatic epithelial basal cells.
The "gatekeeper" gene for "prostatic intraepithelial neoplasia" development is NKX3.1, located on chromosome 8p21, encoding a prostatic specific homeobox gene, essential for normal prostate development, inactive in cancer, and able to repress the expression of Prostatic Specific Antigen (PSA).
PSA, also called Kallicrein 3, is itself a protein involved into inflammatory processes, present at increasing concentrations during prostatitis.
Bearing these pathogenetic considerations in mind, the measurement of PSA total, free, velocity and density for screening pourpose is unjustified in otherwise healthy patients.

john williams | Other | Disclosure: None
November 05, 2011

PSA tests

My prostate cancer was diagnosed indirectlly through a PSA test >4 followed by a free PSA and a biopsy. It was very localized but a gleeson 9. What alternative do you ding dongs have to offer in lieu af a PSA test( the DRE was clear so you can't use that answer!!!)?

SERGIO STAGNARO, MD | Physician | Disclosure: None
RIVA TRIGOSO Italy
November 05, 2011

PSA Evaluation only in presence of Protate Oncological Inherited Real Risk.

To ascertain PSA in all men, without knowing prostate cancer Inherited Real Risk, is neither scientific nor useful.

MR EDWARD JAGO | Other | Disclosure: None
DUBLIN OH
November 04, 2011

Just a survivor's comment

It was suggested that I have a PSA test by my physician some years ago. The test showed a very small level. The test was repeated first at two year intervals and than at one year intevals over a period of about 10 years. My physician plotted the data each year on a time line and we watched first a steady very low increase then an accelerating rate until the last increase showed about a thirty % increase. At that point a biopsy indicated a cancer. I elected surgery and the prostate was removed and the margin cleared. I elected no further treatment be performed. Continued PSA monitoring for the last 12 years has shown no significant PSA so I consider my self prostate cancer free. So I say montitor and watch the trend liine.

MR MARIO GUARNIERI | Other | Disclosure: None
PRATO Italy
November 04, 2011

PSA Screening does help ....

Understand that more prostate volume and more inflammation gets more PSA . However PSA high value does not mean a prostate cancer. There is a helpful new blood test being done in Milan and Firenze, Italy and named P.H.I. (Prostate Health Index) which in my case and others did indicate high-risk of cancer, proven by biopsy. I had surgery on August 31 and am feeling good. PSA will help again this month for deciding whether radiotherapy applications may be advisable or not.

NORMAN SOLOMON, MD | Physician | Disclosure: None
LOS ANGELES CA
November 04, 2011

Advice On Counseling

The dilemma is clear and has been for years. All the anxious waiting for these studies to help clarify what to do have not really changed much. You can explain this to patients till you're blue in face or give them handouts, and they still ask you the same questions. The bottom line is what psychological burdens an individual patient can handle. If learning that ten years from now, they have prostate cancer and if they had only had a psa, maybe things would have been better is something they couldn't handle, then PSA screening is right for them. If they have a poor tolerance for making difficult decisions and would have difficulty knowing that they have a "cancer," but that they are just watching it, then PSA testing would probably be the wrong choice for them. The decision has more to do with what they can handle than it has to do all the facts we bombard them with. I've yet to have a patient NOT ask me at the end of my discussion, what would you do, which shows you their inability in many cases to process the information in a manner that is best suited for themselves.

Jim Thayer | Other | Disclosure: None
November 03, 2011

Missing a most relevant issue

As a researcher supporting the medical and pharmaceutical industry, and a prostate cancer (PC) survivor, I am appalled that so much effort is applied to this issue without considering the most obvious benefit of REPEATED PSA testing. While I did not know that my grandfather had died from metastasized PC until after I had been diagnosed, I had my PSA tested periodically (2-3 year intervals). It was fairly consistent until last year when it increased by several fold (over a 3-year period). I had the biopsy and discovered the PC in time to take action.
While a single PSA test may not be very instructive for all the reasons listed by others, periodic PSA tests are very helpful as they establish a baseline for subsequent comparisons. Because of the current controversy, my physician did not intend to perform the PSA test during my last physical, but I insisted. In my case, it probably saved my life. To me, all this controversy over the value of the PSA test seems ridiculous without consideration of repeated tests to establish a baseline, perhaps best initiated during the age of 45-50.

HANS-HERMANN DUBBEN | Other | Disclosure: None
Hamburg Germany
November 03, 2011

Prostate cancer screening: A controversy about random numbers

Studies on prostate cancer screening are principally not qualified to provide scientifically valid information about a benefit in terms of (cancer specific) mortality. Such trials have too low statistical power because of low cancer-specific mortality combined with long history of disease, lack of compliance, contamination, and unclear causes of death. Trials with sufficient power require millions of participants and tolerate no loss from follow up. Their results become available only decades after trial initiation. Then they are necessarily antiquated due to changes of the population, treatment options and diagnostics. Indispensible prerequisites of science are testable hypotheses and replicability. Neither is a given for early detection of (prostate) cancer. Underpowered studies simply generate random numbers. Thus it is not surprising that the results of the ERSPC and PLCO study are contradictory. Alone the disadvantages are evident because the number of overtreatments are much higher than the number of allegedly prevented PCa-deaths.
Cancer screening studies appear unethical and contradict §17 of the Declaration of Helsinki.

John Costello | Physician | Disclosure: None
November 02, 2011

Internist

The US Task Force stance is correct, but - it changes nothing . The trial in the US may be too compromised to prove the value , and the European trial suggest- with varying criteria for entry, and followup- that screening helps about 1 in 1, 000 or so /year- about the same as mammography, for those likely to live 10 years , between 50 and 65 -70. It's still up to the individual to decide, with the help of a physician/family / friend what is best for them, based on imperfect data. The larger ? is -should a health system pay for such screening?

CHUAN PHING TANG, MD | Physician - Dermatology | Disclosure: None
SITIAWAN Malaysia
November 02, 2011

Find a better treatment

It is agreeable that DRE with PSA screening if done properly will help to pick up early prostate cancer with better accuracy coupled with TRUS biopsy. It is the treatment options to the patient and its complications that put off the patients. PSA screening itself is not a big issue. It is time for the urologist to find a better and less invasive way of diagnosing and treating the Ca prostate. Man is worried of ED,incontinence,retrograde ejaculation... Man wants better quality of life.

JEFFREY HOROWITZ, MD | Physician | Disclosure: None
FALL RIVER MA
October 30, 2011

What is the code for "PSA discussion with patient"?

I can't help thinking about where are we going to find the extra 10-15 minutes to properly discuss the option of PSA screening with our patients. It seems impossible to tack that on to a routine office visit, do a good job and not feel rushed and fall behind schedule all day. Realistically, forget it unless there is a code for it!

GEORGE ADAMS, MD | Physician | Disclosure: None
October 29, 2011

Whenever You Like

It's not yet illegal to check your PSA. I check mine q6 months as that's what Im confortable with. So do what you're comfortable with. Check it whenever you like. You will be as right as anyone else as the final answers are not in and may never be. When it becomes illegal to check it frequently in the US go to Costa Rica on vacation and check it there.

EDUARDO SIGUEL, MD | Physician | Disclosure: None
GAITHERSBURG MD
October 29, 2011

Need Better data, not longer philosophical decisions

Change research and data to offer better data on choices. Build mathematical models probability distributions of types of cancer and treatment outcomes given values of variables such as age, weight, race, nutrient status (such as Vit D and essential fats), family history, prostate size, rate of increase of PSA, treatment type, etc. And chart probability distributions and changes in PSA as a function of biological variability, exercise, lab variability, diet, weight, etc. Develop accurate models of the causes of prostate cancer, the factors that increase or decrease cancer rates. This is feasible today. Instead, we spend millions on useless clinical trials. Current financial incentives discourage better mathematical/biophysical/biological models.
When the data become available, the optimal decisions will usually be obvious. Now, with ignorance, with poorly designed clinical trials, with focus on profits, we don't have data to make optimal decisions and we must obfuscate recommendations.

CLYDE SCHECHTER, MD | Physician | Disclosure: None
CYPRESS CA
October 28, 2011

The PSA Dilemma -- A Result of Entrepreneurial Medicine

So the major trials were seriously flawed. Those in the US suffered from severe contamination in the control group, and screening prior to randomization. Why is that? Because PSA screening was so deeply entrenched in medical practice before it was ever subjected to serious testing. This is typical of entrepreneurial systems: products and services are launched, marketed, and hyped before anyone has time to figure out if they are any good. When it's ordinary consumer goods, probably that doesn't matter much. But here we see that the US undertook a mass campaign of genital mutilation for decades, and the practice became so widespread that it was impossible to mount a valid study of whether we had anything good to show for it. We still don't know if even a single life was saved, and we never will.

The late Thomas Chalmers used to say "Randomize the first patient." His dictum, still ignored, is the wisest advice I have ever heard from any health professional.

James Mohler | Physician | Disclosure: None
October 28, 2011

Clarification on development of the PSA test

While Dr. Ablin did discover a "prostate-specific antigen" that is confined to the normal prostate, he neither developed the PSA test nor discovered the PSA on which the current test is based. That credit goes to Roswell Park Cancer Institute researcher T. Ming Chu, PhD, DSc, and his colleagues, who identified and purified PSA and later developed the simple PSA blood test that is used today for the early detection and management of prostate cancer. The team published its first major paper in 1979 in Investigative Urology, and in 1984, a patent was issued to New York and RPCI and the technology was transferred to the biomedical industry for preparing test kits. The PSA test received FDA approval in 1986 as a monitor for treatment response and disease recurrence and in 1994 as a screening tool for diagnosis. Dr. Chu received the Presidential Award from the AUA in 1993 and was featured in the April 1998 issue of Cancer Research for his research on the use of tumor cell products in the diagnosis and treatment of cancer and for his leadership role in the discovery of PSA and development of the PSA test.

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POLL
The U.S. Preventive Services Task Force recently issued draft recommendations on prostate-cancer screening. In light of the USPSTF report, how would you deal with a 50-year-old, non-Hispanic white man who comes to you for a new-patient appointment? He has no family history of prostate cancer and says that he does not have any lower urinary tract symptoms.
You order a PSA test (you believe a USPSTF Grade A or B recommendation to be appropriate).
15%
You initiate a discussion of prostate-cancer screening with the patient (you believe a USPSTF Grade C recommendation to be appropriate).
46%
Given the modest benefit and potential harms of screening, you do not initiate a discussion (you believe a USPSTF Grade D recommendation to be appropriate).
38%
Poll closed December 1, 2011 (2114 total Responses)