Perspectives on the New PSA Screening Recommendations

This month we asked ONCOLOGY's Editorial Board to informally weigh in on the US Preventive Services Task Force's recommendation against the routine screening of healthy men with the prostate-specific antigen (PSA) test. We asked them to answer the following questions-or provide a free-form response as they wished:

1. Do you approve or disapprove of the new guidelines and why?

2. Do you believe the recommendations, both for PSA screening and mammography, were valid and evidence-based?

3. What do you think is at the core of the PSA decision-reimbursement, avoiding unnecessary morbidity?

4. How do you think groups like the USPSTF could improve on their approach to formulating guidelines for screening tests?

5. How will this affect what you tell patients-both high-risk and not?

Thomas Marsland

Florida Oncology Associates, Orange Park, Florida

This is a very emotional issue. Any time a group claims less screening is good, I always take it with a grain of salt-yet the data certainly seem to support that generalized screening with PSA may not impact survival in the general population. We have recently been down this same path with mammography, so the issues become: who does benefit from screening, and where is it beneficial?

We need better ways to determine tumor biology-which tumor is likely to sit there for years, and which tumor is going to be more aggressive. The life expectancy of the person being screened is also a factor. I completely agree that for patients with limited life expectancy due to another comorbid condition, screening makes little sense. Yet if you are looking at an active, healthy 70-year-old with a life expectancy of 20 or more years, I certainly could make an argument to screen that person. So the issue of subpopulations may very well have impacted these studies. I honestly believe reimbursement is at least partially behind some of these recommendations.

The bottom line is that men are still dying from prostate cancer, and no cancer was ever cured by ignoring it. I would counsel men with life expectancies of 10 years or more to be screened, and continue eagerly to wait for the molecular marker that will tell us which cancers will sit there for 10 years and which ones will behave more aggressively (but even then you'll never find them if you don't look for them...).

Responding to Dr. Marsland

Francis Arena

Arena Oncology Associates, Great Neck, New York

Perfectly stated. I fully agree with Thomas Marsland.

Responding to Dr. Marsland

Allen Yeilding

HOAA, LLC, Birmingham, Alabama

I agree with Dr. Marsland, and basically feel screening mammograms and PSA remain important in early diagnosis and are associated with better prognosis; that it is difficult to quantify the cost of evaluation and management of supposed subgroups who had no benefit from earlier detection, and the savings created by improving outcomes. There are bigger and less politically volatile fish to fry, as both of these procedures also enhance a person's participation in their own well being, instead of the negative of being told the screening isn't "cost effective."

Responding to Dr. Marsland

Charles Penley

Tennessee Oncology, Nashville, Tennessee

I think that Tom Marsland accurately summarized my take on this. The USPSTF is correct as far as it goes. However, there are probably subgroups that will benefit, and identifying them is the trick. Note that they didn't say we shouldn't treat prostate cancer-they just said that there isn't evidence that screening some groups of asymptomatic men results in improvement in survival, and may contribute to unnecessary morbidity. Symptomatic men, or men who are diagnosed by other means, are off the table and not part of this discussion.

The problem with this sort of declaration is that it is often handled poorly. Recall the mammogram issue. The pronouncement came from on high, with no antecedent discussion with other stakeholders. This resulted in an outcry from every corner of the globe. If they had convened a summit, presented the data to all the recognized experts and groups, and then come out with a consensus statement, it would have been received far better by the public. However, I get the sense that this issue was handled in much the same way as the mammography recommendations.

Are we currently overdoing it? You betcha! I've seen many men, well into their 80s, getting their routine PSA screening, then getting the "full monty" treatment when a small asymptomatic prostate cancer is diagnosed. Did that help them? Hard to see that it could.

As with most disagreements, the truth is usually somewhere in the middle. In time, reason will prevail, and we will likely settle in to a "new norm" with respect to screening.

Mike Glodé

University of Colorado Cancer Center, Denver, Colorado

1. I approve because I think the discussions generated are healthy, and when the seminal studies were published earlier, they did not really get the public attention they deserved. The NEJM editorial "Screening for Prostate Cancer-The Controversy That Refuses to Die" was about as good a discussion as you can get.

2. Yes, with the caveat (re: prostate) that the follow-up may show more impact than we currently think for this slow-moving disease.

3. I think it is avoiding unnecessary morbidity. However, as with many, many things in oncology today, we really have to also begin to address cost/benefit in a forthright manner. Not to do so would be an abrogation of our responsibility to society as a whole, and like it or not, we cannot continue on the current path of increasing health care costs.

4. Not sure. I liked the idea that they had an outside group review their recommendations prior to their official release (although it did little to prevent the firestorm).

5. My continued belief is that we do NOT have a truly effective way of communicating the controversy BEFORE the blood is drawn or the rectal exam is done. I think that for high-risk patients (AA, first-degree relatives, BRCA2 families, etc) it is not controversial and I will simply continue to recommend screening. For "average risk" (which is everyone), I am trying to think of ways to do efficient pre-screening education. I did a non–IRB-approved "pilot study" in a group of twelve patients at a free screening clinic. I gave them a 5-minute lecture in groups of three or so in terms of what we know and don't know about screening and went over the PLCO and European data. Afterwards, two declined screening. I think I may try to get a video put together next, and maybe not participate in screening clinics unless/until patients have watched it. I would feel that is more ethical than blindly screening people who simply "believe" and have signed a bunch of paperwork they never really read.

Lee Ellis

University of Texas MD Anderson Cancer Center, Houston, Texas

As a GI person, I do not have much exposure to discussions on prostate cancer. Frankly, I'm happy with the recommendations, as a 50+-year-old male who goes in for an annual physical….Although my PSAs have always been normal, I've always worried about a slightly elevated PSA and then the chase for some indolent cancer . . . this is not like the colon where a polypectomy removes the risk of the development of cancer…prostatectomy or radiation is, of course, a much more morbid treatment…if the science says "no screening," why argue with science? . . . As scientists, we either believe in science or we should not be doing science.

James Yu

Yale Comprehensive Cancer Center, Yale University School of Medicine, New Haven, Connecticut

1. Disapprove. PSA screening is a very complex issue, and a blanket statement about the lack of utility of PSA screening is inappropriate and dangerous. PSA screening provides useful information for an informed discussion of prostate cancer treatment with a patient's physician.

2. I think the panel ignored important observational data in the interest of only focusing on poorly performed randomized trials. They were very narrowly focused.

3. I think the core of the PSA decision is an over emphasis on randomized trials, even poorly run randomized trials, over obvious and strong epidemiologic data. The panel focused on what they thought was unnecessary morbidity. However, there was no oncologist or urologist on that panel as far as I can tell, and no one to tell them that surgery and radiation had progressed since the time of study accrual.

4. They should rely less on simplistic guidelines, and release a statement that recognizes the nuance involved when discussing screening results with men. They could also allow for the inclusion of epidemiological data showing that patients are less likely to die of prostate cancer in the modern PSA era, that there is a lower incidence of advanced disease in the PSA era-and they should include someone with clinical knowledge of the cancer in question.

5. I still encourage screening for all patients. I also encourage watchful waiting in favorable risk patients. I have a very good relationship with my patients – I give them my email address and cell phone number and encourage them to ask me questions. I have no incentive to overtreat (I am a salaried, academic radiation oncologist) and therefore I wholeheartedly encourage watchful waiting when appropriate.

Craig Henderson

University of California San Francisco, San Francisco, California

1. Strongly approve

2. I approve because I believe they are evidence-based. I don't believe there is any more objective group evaluating screening than the Preventive Services Task Force. Having said that, I do believe that sometimes – depending on the membership of the panel – they attempt to be politically sensitive; at other times they seem to be politically tone deaf. For example, their recommendations on breast cancer screening have been more consistent with the available evidence from randomized trials than any other group's, but until recently they supported some soft elements, such as a baseline screening when a woman was in her 40s. However, during the Congressional debates over the new health care legislation they came out with new recommendations that were even more consistent with the data than ever before. Apparently this occurred when it did because of turnover in the membership of the task force. However, it was clearly not a good time to do it in terms of the political climate in the US at that moment!

3. I believe the core of the PSA decision is the lack of evidence that screening improves the prostate-specific survival of men who are screened. A secondary factor is the increased morbidity/mortality from the excessive treatment that results.

4. I believe the USPSTF does it just about right. I don't think improvements are necessary.

5. It won't change anything for me; I've been lecturing for some time and telling the few male patients I see that routine PSA does not improve survival.

Larry Wagman

The Center for Cancer Prevention and Treatment, St. Joseph's Hospital, Orange, California

In general, the criteria for evaluation and the evidence are not always consistent for one group vs another. This leads to discrepancies in the conclusions and hence the recommendations. The mammography guidelines were subject to the above situation, and I suspect the PSA situation is similar. The PSA recommendations are a result of the data and measurement criteria-on the surface, the conclusion reflects a desire to reduce morbidity, false-positive results, and identification of clinically unimportant disease. Improvement of recommendations would likely result in vetting of the recommendations prior to publication and possibly grading of level of evidence by an independent group.

Steven Piver

Sisters of Charity Hospital, Buffalo, New York

I disapprove of the new guidelines. Since 70 is the new 50, the consensus here is that annual PSAs should be continued. After age 80, PSAs should not be done in asymptomatic men. With regard to the mammogram recommendations, the consensus is that, since we are seeing many women in their 40s with breast cancer, annual mammograms should continue. I think avoiding unnecessary morbidity is at the core of the PSA decision.

Bruce Minsky

University of Chicago, Chicago, Illinois

The screening is valuable and still should be performed. The change that should be made is in what we do with the information. It's true that there is probably unnecessary prostate therapy being performed; however, the way to change this is not to stop doing screening-rather, the change should be a more robust doctor/patient discussion about the risk/benefit of further workup and treatment.

Steve Rosen

Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois

I am not an expert, but my understanding is that prostate mortality rates have significantly improved. I see no other explanation but PSA testing. The shortcomings of the trials have been discussed (there are questions concerning the control group).

David Poplack

Pediatric Hematology-Oncology, Baylor College of Medicine

I approve of the new guidelines, and I believe that they were valid and evidence-based. At the core of the decision was avoiding unnecessary morbidity, and the USPSTF can improve on their approach to formulating guidelines for screening tests by doing careful long-term studies before jumping to conclusions

Louis Potters

North Shore-LIJ Health System, Hofstra North Shore-LIJ School of Medicine, New Hyde Park and Hempstead, New York

The issue is that we and our patients are reluctant to not be treated. There is a sense of entitlement toward therapy once given a diagnosis of "the big C." And that allows patients to choose from protons to robots.

The task force data are actually quite clean but do not have enough power to dissect disease risk. Of the three categories of patients (those who will die no matter what is done, those for whom treatment is a waste of time since the disease is indolent or their life expectancy falls short, or lastly, those for whom therapy is effective), it is better to select therapy against the disease risk one falls into (thus allowing research on new and other markers of disease risk). Ergo, from the patient's or the physician/researcher's perspective, the task force leaves us short: we will never know what we do not learn to know about.

If "we" could accept active surveillance for the majority of low-risk patients, then we allow the disease to "declare" itself over time and thus avoid the harms of treatment in potentially many men. That serves the recommendations of the task force (avoiding harm of treatment) as a trade-off for avoiding the harm of biopsy.

Responding to Dr. Potters

Mike Glodé

University of Colorado Cancer Center, Denver, Colorado

Louis has said it well. I have blogged on the challenges at my blog, prost8blog.com. The patient responses are interesting (and predictable). In my view, the problem with surveillance is the emotional burden (never mind the risks of continued biopsies, etc, and lack of level 1 evidence for this approach vs treatment in terms of survival-we failed to recruit successfully to Lawrie Klotz's randomized trial, as did everyone else...). No one really wants to "just watch" a cancer grow, even if the risk of metastasis is finite and small. The happiest are those who don't know they have indolent disease or have none at all, but our current technology can't separate them out and keep them from finding out.

David Crawford

University of Colorado Health Sciences Center, Denver, Colorado

In 1989 we started Prostate Cancer Awareness Week to educate men about prostate cancer and promote early detection because it was that year that the disease became the number-one cancer diagnosed in American males and the second leading cause of death. We had no idea whether screening would work, but we did know that the majority of cases of the disease diagnosed then were advanced and incurable.

As chairman of this group since inception, I realized that we had no level 1 evidence to support early detection. Our event was very successful and remains the largest screening event for any cancer in the world. The number of cases of advanced disease plummeted. We found more early cancers, and the pendulum began to swing too far the other way: we were finding many cancers that appeared to be non-threatening, and there was a masterful marketing scheme by a company selling so-called robots and a proliferation of expensive radiotherapeutic techniques. And rather than focus on who needs to be treated, we entered an era of overtreatment in some men.

At the same time an ongoing US trial called the PLCO demonstrated that screening did not alter mortality. I was the principal investigator for one of the ten US sites. This trial was ignored by the mainstream, while a weakly positive trial from Europe was embraced. So the US Preventive Services Task Force have reviewed the data, including the current report which concludes that screening is not appropriate.

So what should we do? The truth lies somewhere in between. We should not return to 1989 when advanced disease dominated; rather, we should prudently screen men and separate diagnosis from treatment. We should strive to determine who could benefit from treatment. We need new markers of aggressiveness. We need to resist the marketing strategies of companies who mislead the public. We should acknowledge the very thoughtful conclusions of this task force and respond during this time of analysis with a plan to evaluate how to somehow eradicate the pain and suffering from this disease. We need to alter the death rate. We should work with organizations like the AUA and others to achieve this goal

Lodovico Balducci

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

1. I wholeheartedly approve. The guidelines have never been evidence-based, and the evidence is not there to support them. In the meantime, there is a lot of evidence of the damage done by treating people who don't need treatment.

2. I don't know of any PSA guidelines that are evidence-based. The mammography guidelines are based on some evidence for women aged 50+, but a number of questions are still open-especially whether you need to screen every 2 years, whether in older women (70+) mammography or other imaging techniques are superior to physical examination of the breast by a professional.

3. Avoiding unnecessary morbidity is the main reason. Avoiding unnecessary costs is also important. In the management of prostate cancer, we waste billions of dollars every year doing a lot of damage and showing no evidence that we are doing any good.

4. The USPSTF has the best approach and should not improve on anything

William Hoskins

Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York

I do think the recommendations were based on a review of available data, but the decision to recommend changes in the screening criteria are based on the rather subjective interpretation that the side effects of the screening (anxiety, negative biopsies, etc) are harmful to the patient. In both cases, however, there will be some early cancers not picked up that might have otherwise been diagnosed early. While this may not be sufficient to cause a significant shift in survival, for the individual patient, they may be significant. My institution and the experts in breast and prostate cancer here have elected not to change their recommendations-ie, annual mammograms for women after age 40 and annual PSA until age 70.