It’s Time to Lay Down Our Rhetorical Arms and Get to Work

The recent USPSTF recommendation on PSA provides a teaching moment and an opportunity to move entirely beyond the PSA debate. But will others heed the call?

Emotions are running high ever since the USPSTF released their most recent recommendations on PSA screening last week. The patient advocacy community is running at a fevered pitch. The task force continues to defend its position. Leading organizations are responding as best they can while balancing multiple considerations and constituencies. Standing back, I see a lot of wasted emotions and energy, and not many real solutions being offered. It’s as if some of the players want to hold onto business as usual, drawing their raison d’etre from the controversy rather than calling for a time out and collectively defining a reasoned, science-based plan for curing more and overtreating less. The levels of unbridled passion exhibited threaten to erode credibility.

All sides need to acknowledge that the PSA test is not a cancer test and that it has its limitations. We also need more informed consent BOTH before and after PSA screening. Most importantly, we need to acknowledge that overtreatment of prostate cancer is as serious a problem as aggressive varieties of prostate cancer and the 33,000 deaths of American men they cause each year.

Yes, I, like many of the readers of this blog, believe that PSA screening saved my life. BUT… for as many of us as there are, there are many men who have been overtreated as a result of their diagnoses and suffer needlessly the possible consequences.

Cancer is a scary word. With more than 25 genotypes or varieties of prostate cancer, and no way yet to discern specifically between non-life-threatening and aggressive types in the current diagnostic process, overtreatment remains a problem. In my case, I might not particularly like the procedures and treatments I have had to and continue to endure, but I am blessed to be able to sit here and write this entry. However, I would not wish this reality on any man or family whose cancer doesn’t merit a similar course of treatment.

Advances in developing better diagnostic tests will soon ensure that we are serving the needs of men on both sides of the prostate cancer spectrum. One very promising example is the development of a new genetic-based urine test developed by researchers at the University of Michigan.

 

I have been working with the Prostate Cancer Foundation for three and a half years. This weekend, I put in many extra hours working with our leadership team and medical director, outlining our response to the USPSTF recommendations on PSA screening. I am proud to run the response in its entirely here. I hope all sides will see the logic behind the statement and push for greater collective investments in coordinated research.

We are so close to moving beyond this quagmire. It’s time to turn down the volume and turn up the action. Together, we can cure more and overtreat less.

PCF RESPONDS TO U.S. PROTECTIVE SERVICES TASK FORCE RECOMMENDATION ON PSA SCREENING

While needing better guidelines, the PSA test still plays an important role in detecting early prostate cancer in informed patients

LOS ANGELES/October 10, 2011—The mission of the Prostate Cancer Foundation (PCF) is ending suffering and death from prostate cancer through research. PCF received a copy of the U.S. Preventive Services Take Force report late Friday. Today, PCF issued its analysis of the heavily-debated recommendations of the U.S. Preventive Services Take Force regarding PSA screening in healthy men.

The Prostate Cancer Foundation:

•         Supports continued routine PSA screening of informed patients until new American Urological Association clinical guidelines on PSA screening are issued and disseminated.

•         Supports a patient’s choice to have a PSA test. The decision should be made between a man and his personal physician based on his individual status with respect to age, symptoms, family history or concerns about prostate cancer.

•          Supports American Cancer Society communications calling for far better processes of informed patient decision-making both prior to, and after, PSA screening in healthy men.

•         Opposes the elimination of reimbursement for an informed patient requesting screening.

•         Strongly recommends intensified National Cancer Institute focus and research investment in better early detection tests of lethal prostate cancers. We also recommend new public-private research partnerships drawn from substantially increased and coordinated research investments from the American Cancer Society (ACS) and the American Urologic Association (AUA) partnering with the NCI and PCF.  Such public-private partnerships will accelerate the discovery, testing, and validation in U.S. men of new biotechnologies for lethal cancer detection that are superior to PSA screening.

•        Calls for greater patient participation in clinical studies evaluating new genomics-based prostate cancer detection tests.

•        Calls for greater eligible patient participation in and physician referral of patients to ongoing new clinical trials evaluating Proactive Surveillance (watchful waiting).

Additional Observations

The USPSTF has heightened awareness with new data of the issue of severe complications and patient suffering from the overdiagnosis and overtreatment of indolent prostate cancers. In addition to the emotional and physical suffering experienced by men and their families, a recent cost-effectiveness analysis of PSA screening estimated that the cost of diagnosis and treatment is over $5,227,306 per patient to prevent one U.S. prostate cancer death.

The USPSTF’s position provides a teachable and actionable moment for the medical community to improve targeting of PSA screening in patients, reduce over-testing and improve processes of patient education on the risks of overtreatment from PSA screening.

In the abstract, “task force” recommendations can create patient confusion and may result in unquantifiable numbers of men who will get a delayed diagnosis of a lethal and curable cancer. However, it should be noted that the recommendation clearly states, “…while the USPSTF discourages the use of screening tests for which the benefits do not outweigh the harms in the target population, it recognizes the common use of PSA screening in practice today and understands that some men will continue to request and some physicians will continue to offer screening. An individual man may choose to be screened because he places a higher value on the possibility of benefit, however small, than the known harms that accompany screening and treatment of screen-detected cancer, particularly the harms of over diagnosis and overtreatment. This decision should be an informed decision, preferably made in consultation with a regular care provider. No man should be screened without his understanding and consent; community-based and employer-based screening that does not allow an informed choice should be discontinued.”

PCF is encouraged that the AUA has convened a panel of medical experts who work routinely with prostate cancer patients, to improve guidelines for more targeted use of the PSA test as a screening tool.

Moving Past the PSA Debate

The PSA test still has a role to play in early detection and treatment for millions of men. It should be noted that in the pre-PSA era, approximately 80% of patients who were diagnosed with prostate cancer, were already in advanced stages of the disease with metastatic cancer. Today, the number of patients who are diagnosed with metastatic disease at time of initial diagnosis is around 20%. In the past 15 years, the death rate has been reduced from 42,000 annually to 33,000.

The PSA debate can become moot with intensive and accelerated research that delivers a better test. For more than a decade, PCF has been supporting research to find new and better molecular biomarkers for prostate cancer. At PCF’s 2011 Scientific Retreat, data on 17 new biotechnologies that complement or have the potential to replace PSA screening was presented. Many of these biotechnologies have the potential to discern between indolent and lethal prostate cancers. Essential will be patient participation in clinical trials to evaluate these new tests. New data on urine and blood tests using genetic biomarkers also offer the promise of eliminating a large number of unneeded biopsies and subsequent
unnecessary treatment.

Given the enormity of the problem of overdiagnosis and overtreatment, PCF is also supporting a $5 million research project, the National Proactive Surveillance Network, to determine which patients can be maintained on proactive surveillance and which patients need to be recommended for surgery or radiation. Additional clinical trials of proactive surveillance are urgently needed to develop guidelines for men whose cancer is not life-threatening.

To keep apprised of the latest developments related to the USPSTF Recommendations on PSA Screening visit PCF’s special Resource Center.

Yours in health… –Dan

Twitter Digg Delicious Stumbleupon Technorati Facebook Email

19 Responses to “It’s Time to Lay Down Our Rhetorical Arms and Get to Work”

  1. Well said. Imagine what we could do if we had even half the resources spent on breast cancer.(not that we should stop spending on breast cancer ) If the PSA is truly lacking, then find a better test don’t throw this one out. If PSA is costing this much any investment in a better array of tests is worthwhile. Routine mammograms have been quetioned at times because of risk of over biopsying, but no one has tried to makis broad brush reccomendation to eliminate them. More research and bettertests need to be found. stopping PSA testing is tantamont to sticking your head under a rock.

  2. Well said, Dan. The PCF response is measured and intelligent.

    One bullet point I would have added to the PCF press release is to encourage people to write their Representatives and Senators to continue (if not increase) funding of the DOD-managed Prostate Cancer Research Program (PCRP), whose goals are very similar to those of the PCF. There are about fifty of us “consumer reviewers” (guys who are survivors or are still being treated) here in Reston, Virginia this week, who’ve laid down our rhetorical arms, and are working with several hundred scientists performing peer review of many grant applications proposing to perform high risk, high return research to distinguish indolent from aggressive disease. Essential research that will help get us beyond the PSA era.

    And just one other small request: could we get the prostate cancer community to agree on the term formerly known as “watchful waiting?” Expectant management? Active Surveillance? Proactive surveillance?

    • Craig and Dan have many valid points in the PSA versus no PSA controversey. I would like to add to the discussion as a stage 4 prostate cancer victim. I am also diagnosed
      with muscle invasive bladder cancer. So I am not unfamiliar with urologic cancers.

      The PSA can alert men to pay attention to this area of their health care. When I was first diagnosed I had a PSA of 522. The only way I could explain it was that I must be an overachiever. Since then we have been able to reduce that to between 2 and 3.

      I am told that I am treatable but not curable. And am enjoying all the accompanying treatment joys of advanced prostate cancer.

      I see research as the key to improving the system and the outcomes for men in all of the various stages. But we must get it together and focus our efforts. That may well require prostate cancer organizations to work cooperatively. After all, the fight is against prostate cancer and how it ravages it’s victims. No against one organization or another.

      When I see the pink ribbons all over the place, I wonder where are the blue ribbons. Men will have to get it together in order to get our share of research funding. Only by doing so, can we resolve the PSA debate. But let’s not throw out the baby with the bathwater just because the water temperature is not to our liking.

      • Thank you, Jim. I am glad to see that you have given up the overachieving on your PSA and that you are now down to a more reasonable 2-3!

        Wishes for continue success with yor treatments.

  3. I am a physician and currently have prostate cancer that we are watching. There are too many aggressive Urologists (Many who have to pay for their new Robot). That is part of the message of the task force. Just because you have a cancer diagnosis doesn’t mean you need treatment. It is a long and hard conversation with patients to convince them they don’t need any treatment. Urologist have to take the time to have this conversation. Throwing out the PSA however is horribly short sided.

    • Thank you, Greg. I believe will soon get the point where science will make that patient discussion easier for physicians and give patients more confidence in cases where the best treatemnt is no treatment.

      As for your personal case of cancer, I hope you’ll be watching it lay low for a lifetime!

  4. Where does the $5,227,306 per patient cost in the USPSTF report come from?

  5. As somebody who has undergone a Radical prosectomy, a full course of Radiation and now Hormone therapy all with a PSA count that was and still is very low I can’t help but think that an alternative test in conjunction with the PSA would have been very critical in terms of the decisions I have made based on the recommendations of the medical specialists I have entrusted with my care. To the PCF I am grateful for your stance. Well done.

  6. I’m a seven year survivor. Diagnosed in 2004 with PSA of 51 (yes 51), biopsy results were stage T3a, Gleason 8 cancer fortunately confined to prostate. Treated with hormones and radiation and now cancer free. I consider myself fortunate in view of the stage of the cancer when diagnosed. Where would I be if the USPSTF discouraged PSA tests in 2004?

  7. Dan,

    The PCF stand is of course right on. I commend and agree.

    My interest, however, now focuses on the merits of the PSA during treatment. After 9 weeks of radiation and a full year of Lupron shots, not once has either my urologist or oncologist done a digital probe if anything to see how things feel/look–where there were bumps, what’s there now?

    It seems that the only marker being used to track treatment is the PSA test, and we all know that the test is not complete in what it finds.

    So I ask: is work being done to not only find better and more successful treatment modes, but to learn how to better qualify ongoing treatment?

    • Tom,

      Of course, I am not a physician, but I would certainly ask during your next visit so you can get your questions answered to your liking. I would be interested in the answer as well. Is the DRE not used because of possible scarring? Just not valid? Curious minds want to know.

      Until we have new biomarkers, I believe that PSA plays a much less questionable role in measuring response to treatment. But that’s another good question for your physician.

      Wishing you continued success with your treatment.
      Dan

  8. Dan,

    Without doubt, I will be asking the questions in my next visit with the oncologist–November.

    I had planned to ask the questions two weeks ago when I was scheduled to get a Lupron shot at the urologists office, but he was a no-show! He’s leaving his NY practice and moving to another state, so now I need to find a new urologist–or maybe not.

    In any case, PSA screening seems to be carrying a heavy load…

  9. I would like to thank you for your effort to inform the public that the recommendation of the US preventive task force to stop PSA screenings is based on fundamentally flawed thinking. Take, for instance, my case.

    At age 50 in 2006 my first ever PSA screening detected a higher than normal PSA level (above 2.5). Since my family doctor could not feel a cancer in my prostate he referred me to a urologist who repeated the PSA test. I completed a questionnaire which basically told my doctor that I have some urinary symptoms due to my enlarged prostate. This result was apparently confirmed when a treatment with antibiotics reduced my psa by 50%. However within 12 months my PSA level was elevated again.

    As a consequence, I was included in a group of five patients for biopsy in 2008. Besides one low grade PIN 24 samples did not show any sign of cancer. Hence the conclusion that the PSA test was unnecessary and had as a consequence an expensive and equally unnecessary biopsy. One of the other four patients with urinary symptoms but normal PSA had stage III cancer to the surprise of my doctor.

    In 2009 and 2010 my 6 month interval PSA screenings fluctuated between 3 and 4. Again I completed questionnaires which basically linked my elevated PSA level to my apparently enlarged prostate. My questionnaires, my PSA screening tests and the result of my biopsy were added to the national data on prostate cancer. They seem to confirm the recommendation of the US preventive task force. At the beginning of 2011 my PSA rose again from 3.8 (October 2010) to 6.1 (February 2011). Instead of another Biopsy my doctor suggested a genetic test which should detect cancer cells in the fluids of the prostate. Again this test showed no sign of cancer.

    My doctor submitted my case to other specialists (second opinion) who recommended a new biopsy. In April 2011 the result of my second biopsy showed one high grade pin and 23 samples free of cancer. To my surprise my doctor did not believe the results of the biopsy and suggested to the dismay of my health insurance a new biopsy in June 2011. My wife complained that my doctor seems to be obsessed with the detection of non-existing cancer. The third biopsy in June 2011 detected near the high grade pin area a stage II cancer in my prostate.

    I am scheduled for surgery by the end of October. I hope that the surgery confirms a lower stage. If my doctor had followed the standard protocol (accept the result of the second biopsy) as well as the recommendation of the US preventive task force, I would still be “cancer-free”. Perversely before the third biopsy my medical data sample set would have confirmed the accuracy of the existing methodology.

    I personally believe that one of the sources of the problem is the questionnaire which is biased with respect to an enlarged prostate and contains questions that cannot and will not be accurately answered by the patient (assign an index number to impotence, incontinence, urinary symptoms etc.) if the detection of cancer might have impotence as a result. Men lie when confronted with this perspective. The second problem is that my false-positive biopsies will probably not be corrected in the national data set.

    The last problem with the existing methodology is more serious. For men over 50 years old impotence or infertility should not be a primary medical consideration. Also the preventive task force should be better informed with respect to old age incontinence. Prostate cancer treatment is not the only medical condition that might put men in diapers.Otherwise there would be no adult diapers on the baby shelf in supermarkets.

  10. Hi all, the information we received earlier this week that your senate wish’s to abolish the PSA is a ungraceful matter for men all around the world.
    We PC survivors would not be alive today without it, and i wonder if any of them have been down our road with PC (probably not)
    As a facilitator in our own support group i work 24/7 to promote mens health especially PC testing. Whats a blood test? a life saver as a mammogram is to BC.
    America has till now been a world leader in all health matters and science, so why fall over now? this i dont understand as an Aussie.

  11. While the so needed cancer research continues, little is being done for the sufferers with benign prostate.

  12. The U.S. Preventive Services Task Force regarding PSA screening is wrong concerning the elimination of the annual PSA test.

    If it wasn’t for PSA testing I’d be dead today. I get an annual physical every year which includes a complete blood workup and a PSA test ( over 10 years of an established base line) . In 2008 my family MD noticed my PSA was several points above my base line and recommended I see an urologist. My urologist found a lump and a biopsy determined it was cancerous and more aggressive than ordinary prostate cancer. I elected surgery and after removing the prostate they found the cancer to be extremely aggressive – it had moved to my lymph nodes. After hormone treatment and 45 sessions of radiation therapy I was clean of cancer and am still clean 3 years later. My surgeon still proclaims how amazing I am and how I’ve beaten the odds on survival. I’m a living example that PSA tests save lives. The percentages may be low for surviving aggressive prostate cancer but if you catch it in time you can still save lives.

    I’m 61 years old, my PSA is undetectable and I’m still looking forward to my retirement.

    Rich Poirier

  13. As somebody who has undergone a Radical prosectomy, a full course of Radiation and now Hormone therapy all with a PSA count that was and still is very low I can’t help but think that an alternative test in conjunction with the PSA would have been very critical in terms of the decisions I have made based on the recommendations of the medical specialists I have entrusted with my care. To the PCF I am grateful for your stance. Well done.
    Social Bookmarks

Trackbacks/Pingbacks

  1. Blocking the Stream of PSAs « Public Health Evolved - October 18, 2011

    [...] in some men the cancer will never create a health risk, but who is to say in whom it will develop? Dan Zenka, a prostate cancer survivor seems to think that PSAs are useful even if they save one life. Others [...]