Screening for Prostate Cancer: U.S. Preventive Services Task Force Recommendation Statement
DRAFT
Summary of Recommendation and Evidence
The U.S. Preventive Services Task Force (USPSTF) recommends against prostate-specific antigen (PSA)-based screening for prostate cancer. This is a grade D recommendation.
This recommendation applies to men in the U.S. population that do not have symptoms that are highly suspicious for prostate cancer, regardless of age, race, or family history. The Task Force did not evaluate the use of the PSA test as part of a diagnostic strategy in men with symptoms that are highly suspicious for prostate cancer. This recommendation also does not consider the use of the PSA test for surveillance after diagnosis and/or treatment of prostate cancer. The full text of the draft recommendation can be viewed here .
The USPSTF called for comments on it’s draft recommendation here .
Below are the comments of William J. Catalona, MD. 
Dr. Catalona is Professor of Urology at Northwestern University Feinberg School of Medicine. He is affiliated with the Robert H. Lurie Comprehensive Cancer Center. Dr. Catalona is currently conducting research into the genetics of prostate cancer which could lead to new tests for the disease as well as possible new means of treating or preventing prostate cancer. He specializes in prostate cancer surgery and is recognized as an expert in performing the “nerve-sparing” radical prostatectomy that can preserve sexual potency. He is the author of over 371 publications.
How could the USPSTF make this draft Recommendation Statement clearer?
1) The draft recommendation statement includes misinformation and ignores other important information. This needs to be corrected, not just for clarity but for accuracy.
2) Contrary to What Dr. Virginia A. Moyer, the pediatrician who chaired the USPSTF panel has said in the popular media, the USPSTF should acknowledge the evidence that screening in certain patient groups, such as healthy patients and younger patients, reduced prostate cancer (PC) death rates.
3) It is important to bear in mind that the primary endpoint of the randomized clinical trials (RCTs) was PC-specific mortality, not all-cause mortality. The RCTs were neither designed nor powered to evaluate all-cause mortality. However, it is possible that with longer follow-up, the all cause survival will be significantly longer in these patient populations screened with PSA. The USPSTF therefore needs to acknowledge that PSA screening has been shown to reduce deaths from prostate cancer, and that follow-up was too short in the existing studies to adequately address all-cause mortality (see below).
4) The USPSTF recommendation does not take into account the “number needed to treat” (NNT) to prevent 1 case of metastatic disease. This NNT is much lower than that to prevent to prevent 1 PC death. Preventing advanced disease causes a reduced financial burden on the healthcare system and an incalculable reduction in human suffering.
5) Data from the low-quality randomized clinical trials (RCTs) or RCTs designed with a different goal should not have been combined in metaanalyses with data from 2 higher quality RCTs that showed substantial PC mortally benefits. In this regard, Roobol et al called the metaanalysis by Djulbegovic et al “seriously flawed.” In contrast, the ERSPC and Goteborg trials showed that PSA screening resulted in 20% and 44% reductions in PC mortality, respectively. Dilution of the mortality benefits by combining the data from heterogeneous trials was foreseeable.
6) USPSTF should also acknowledge the 44% mortality benefit with a NNT to prevent 1 PC death of 5 in the healthier PLCO trial subgroup reported by Crawford et al.
7) USPSTF should explain that PSA screening as performed in these RCTs is not representative of the way PSA screening is currently practiced today, and thus the results are of limited current relevance.
8.) In this regard, in the Goteborg trial, nearly 40% of the screened men who died of PC were diagnosed at their first screening visit. In fact, all the RCTs were initiated early in the PSA era, and many of the PC deaths in the screened arms occurred in men with advanced PC diagnosed on their first screen. With serial screening the PC mortality benefit would be greater.
9) USPSTF should acknowledge that high-risk populations, such as African-Americans, have not been adequately studied for PC mortality benefits.
10) USPSTF totally ignored the > 40% reduction of PC mortality – more than for any other cancer in men or women — in epidemiologic data from the Surveillance, Epidemiology and End Results (SEER) data from the U.S. and similar patterns in the global World Health Organization (WHO) data during the PSA era.
What information, if any, did you expect to find in this draft Recommendation Statement that
was not included?
1) Subgroup analysis of healthier PLCO men (44% mortality benefit with NNT= 5)
2) All of the RCTs have evaluated only the early effects of screening. For example, 5% of deaths in Swedish men are caused by PC. In the Goteborg trial with 14 years of follow-up, the absolute PC death rate was 0.9% in controls and 0.5% in screened men. Thus, if, as expected from the Swedish data, 5% of the controls ultimately die of PC, we have observed less than one-fifth of the PC deaths that eventually will occur in this patient cohort. And, if the relative risk reduction for PC mortality is sustained, they could end up with a 2.5% absolute mortality benefit rather than the 0.4% absolute benefit first reported.
3) The epidemiologic evidence that screening decreases PC mortality; SEER data shows 75% decrease in metastases at diagnosis during PSA era and 40% decrease in the age-adjusted PC mortality; WHO data show similar trends in countries where PSA has been adopted but not where it has not
4) Citing NCI modeling team study estimating 45-70% of the PC mortality benefit is directly attributable to PSA screening
5) Citing NCI modeling team’s lower estimates of over diagnosis using U.S. statistical models with SEER data compared to the widely-quoted Rotterdam models
6) Citing data from surgical series showing that underdiagnosis is more common than overdiagnosis in patients treated with radical prostatectomy. PC is still detected too late more often than too early; the true magnitude of the risk of overdiagnosis of PC is largely unknown.
7) Pointing out that men with a 10-year life expectancy would have more options and a better chance of avoiding metastases and death from PC by having a discussion of the benefits and risks of PSA screening and then proceeding according to NCCN guidelines
8.) Pointing out that patients needing treatment can be informed about all of the options and seek expert doctors for treatment with fewest side effects
Based on the evidence presented in this draft Recommendation Statement, do you believe
that the USPSTF came to the right conclusions? Please provide additional evidence or
viewpoints that you think should have been considered.
I believe the USPSTF committee not only came to the wrong decision, but, if implemented, the resulting effects would be harmful, life-threatening and unconscionable.
1) They did not review all relevant literature, nor did they interpret it properly.
2) The AUA and the ACS have adopted positive recommendations for screening, and NCCN guidelines help implement screening.
3) USPSTF’s recommendation polarizes the medical community and confuses patients and physicians.
4) Over diagnosis and over treatment are exaggerated in the literature and popular media.
5) I have prepared an article that summarizes evidence that should have been considered in the recommendations but was not: See www.drcatalona.com page 1 article: Ramon Guiteras Lecture: Early Diagnosis of Prostate Cancer through PSA Testing Saves Lives
What resources or tools could the USPSTF provide that would make this Recommendation
Statement more useful to you in its final form?
I don’t believe this recommendation statement is helpful or accurate no matter what additional tools are provided. Instead, more accurate information would need to be provided.
1) Point out that high-risk men have not been adequately represented in the studies reviewed by the USPSTF; avoiding PC death may be more important for them.
2) Include urologists and cancer specialist on the panel.
3) Point out that the NNT to prevent metastases and PC death is lower in younger, healthier men, in those trials that continue screening for many years, and in those that have longer follow-up.
The USPSTF is committed to understanding the needs and perspectives of the public it serves.
Please share any experiences that you think could further inform the USPSTF on this draft
Recommendation Statement.
1) Because the cancer begins on the prostate’s outer edges, it produces no symptoms until it is far advanced and too late to cure. An apparently ‘healthy’ man may have a steadily climbing PSA, silently trumpeting the danger alarm.
2) African-American men were not included in studies used to make the guidelines and they are a group that benefit greatly from PSA screening.
3) USPSTF recommendation could result in insurance not covering screening; this would be disproportionately detrimental to men in the African-American community who are 50% more likely to be diagnosed with PC and 200% more likely to die of it and unnecessarily increase healthcare disparities in the U.S.
4) Side effects of prostate cancer treatment are greatly diminished with expert surgeons and ongoing improvements in treatment
5) Gann et al reported studies reflecting what would happen if all PSA screening were to stop. In a study of the relationship between PSA values in blood samples drawn before the PSA era from the Physician’s Health Study, in men who subsequently were diagnosed with PC and died, the cause of death was PC in 75%.
Do you have other comments on this draft Recommendation Statement?
1) PSA is the best screening test available for the early diagnosis prostate cancer, and until there is a replacement for PSA, it would be unconscionable to stop it.
2) The risk of possible side effects should not be used as a fear tactic to discourage life-saving PSA screening and treatment.
3) When I first started my prostate surgery practice more than 30 years ago, I would too often have to stand at the bedside of a patient and his family and tell them the operation went well, but the cancer had spread beyond the prostate and the prognosis was not good. Even with the development of nerve-sparing surgery in the early 1980s, I had to say the same thing. Soon after the beginning of the PSA era in the early 1990s, there were far fewer patients with advanced disease. Because of early detection through PSA testing, the radical prostatectomy allowed for a cure in most patients, and the PC death rates plummeted. Now, I am concerned, with the USPSTF’s recent misinterpretation of studies and ill-advised recommendation, we will see a return to most patients with advanced disease at diagnosis.. It is a sad occasion for surgeons, patients, and patients’ families. The outcry against the USPSTF recommendation from the cancer community resonates — nobody intimately involved in the care of prostate cancer patients on a daily basis wants to go back there!
October 2011
Only those with advanced prostate cancer could say it better.
I am a former patient of Dr Catalona. I am 45 yrs old and was diagnosed in April 2011 during a routine PSA test due to me taking testosterone supplements. It was removed via nerve sparing open radical prostatectomy. I do not see how this group can make a blanket determination like this without looking at the whole picture. They are doing a disservice to males out there with their statements. Would this task force have been willing to be the ones that would have had to tell my two teenage daughters and wife, “We are sorry but we were wrong” because I would not have been able to have caught it early enough to save my life? I think not. My Gleason before surgery was 3+3=6 and 3+4=7 after. Dr Catalona got it out just in time as it was encroaching on the prostate’s membrane.
It is my understanding that this task force didn’t even have a urologist or oncologist in the group. Is this how we are going to advance into the future? Obviously, practice does not make perfect here! With that said…Dr Catalona has now performed more than 5,000 radical prostatectomies, more than anyone else in the world. Dr. Catalona is one of the first surgeons to perform and perfect nerve- sparing surgery in radical prostatectomy operations. His patients have come from all 50 states in the United States, as well as from Asia, Europe, the Middle East, and Central and South America. Knowing this…who will you believe? ITS A NO-BRAINER FOR ME!!!
WOULD ANY GROUP SUGGEST THAT THEY SHOULD STOP GIVING MAMMOGRAMS TO ANY SEEMINGLY HEALTHY WOMAN!!! AFTER ALL THERE MAY BE FALSE POSITIVES!!! I WAS A SEEMINGLY HEALTHY MAN OF 49 WHEN I WENT FOR A ROUTINE CHECK UP. IF MY INTERNIST HAD NOT NOT ORDERED A PSA TEST ON ME , I WOULD ALMOST CERTAINLY BE DEAD !!! MY PSA WAS 54.7. I HAD A PROSTATECTOMY, MY PSA WENT TO .01, AND THEN STARTED RISING. THIS AFTER THE MARGINS WERE CLEAR, AND ALL LYMPH NODES CAME BACK CLEAN. I’M ON LUPRON, AND CASODEX. IT IS SEVEN YEARS LATER, AND I’M STILL HERE AND FIGHTING. ONLY BECAUSE OF A BLOOD TEST, I’VE BEEN ABLE TO SEE BOTH OF MY CHILDREN GRADUATE FROM HIGH SCHOOL, AND COLLEGE, AND SEE OUR 25TH WEDDING ANNIVERSARY. I KNOW OF TWO OTHER PEOPLE THAT WERE MY AGE, DIAGNOSED AROUND THE SAME TIME, WHO HAVE NOT MADE IT. IT IS LUDICROUS TO TAKE AWAY A SIMPLE TEST ON THE GROUNDS BEING CITED. HIS RESPONSE IS DEAD ON THE MONEY.
As someone who just had a radical prostatectomy in July one of my main concerns is for my two sons. Although they are young now (21 and 23), with past history of prostate cancer in their family (father, grandfather, and great – grandfather) how will they be able to effectively have their status checked? A simple DRE (digital rectal exam) is not accurate enough, from what I understand.
Steve (above) – I’m with you almost all of the way. My journey has been nearly identical. My diagnosis was at 49 also and I am on Lupron and Casodex also. It’s been 8 1/2 years for me and I am very grateful for a doctor at the Mayo Clinic who used the PSA to diagnose my prostate cancer. The USPSTF is doing men a major disservice by their recommendation!! And thank you Dr. Catalona for you comments. It is a very good thing that someone with such a comprehensive background with prostate cancer is speaking out against the USPSTF recommendation!
Dr Cantalona thank you for the thoughtful remarks. I have read a great deal of your work and the comments that you make are “spot on”. As a PC benefactor of early PSA screening, I was successfully treated at 46 years old. Where would I be if I had waited.
No PSA tests? This is simply unconscionable, I cannot imagine a world where we put our male population at such risk. Speaking from my own experience, it was my first PSA test at age 50 that led to the ultimate discovery and confirmation 18 months later that I had cancer. And it was continued rising PSA results that kept the doctors involved and on the path to a diagnosis. So without that single/first PSA test, and subsequent rising PSA test results driving the doctors to continue looking for the issue, there’s no way anyone would have known I had a 4+3 Gleason score tumor. And I certainly would not have pursued any course of action. Like why would I? Never-ever were there any physical signs that anything was amiss….talk about a silent killer. I can see it now. “Hi Doctor, I’m in the best physical shape of my life, my half marathon times continue to improve month after month, so please would you consider doing some exploratory surgery or invasive analysis just to make sure I don’t have prostate cancer?” Ya right.
In the past eight years I have tested virtually zero when it comes to PSA, and now wonder what I’m suppose to do as a follow up; hope, trust in the all mighty that there’s no chance of recurrence, wait till there’s some other physical sign, what exactly am I suppose to do? What the heck, why do any testing for anything, if not to drive early possible diagnosis and increased levels of testing?
Three final thoughts.
First: I saw my father pass due to complications from prostate cancer, and while the official coroner’s report stated heart failure, it was heart failure due to those cancer based complications. And while he fought cancer for many years, I can only think without his early PSA tests, and the follow on procedures, the prostate cancer would have killed many years earlier.
Second: This sounds like a blatant cost saving measure on behalf of the large insurance companies. And I am certain they evaluated the probability of making this cost cutting change and the likely non-reaction this would elicit from the male population. Most males are in such denial when it comes to blood tests, and PSA tests in particular. I’m certain the marketing based analysis is telling the major insurance companies this is one change they can make, and can make it with little to minor (male based) public reaction.
Third: Wonder what would happen if the same large insurance companies would make a similar recommendation for pap smears or mammograms?
I’m a 5 year survivor of prostate cancer. If it had not been for the PSA test the cancer would not have been detected until it had advanced to a stage witch may not have been treatable. I saw 5 doctors and none were able to feel the tumor. After the surgery it was determined that the cancer was starting to get more aggressive. The waiting for the cancer to grow to a stage where it can be detected by a DRE is not a real option.
The PSA test is just that a test. It is no different than taking an EKG to find a problem. The risk of false positive is small compared with the risk of not finding the problem until it has spread the bone or some other organ.
To those who say Prostate cancer will not kill you I say 5 of my friends and one cousin who died of the cancer.
John P Snelling
Modesto Ca