Debate Persists Regarding PSA Screening for Prostate Cancer (printer-friendly) Page 1 of 7 www.medscape.org This article is a CME/CE certified activity. To earn credit for this activity visit: http://www.medscape.org/viewarticle/756632 CME/CE Information CME/CE Released: 01/10/2012; Valid for credit through 01/10/2013 Target Audience This article is intended for primary care clinicians, urologists, geriatricians, oncologists, and other specialists caring for patients in whom prostate cancer screening may be appropriate. Goal The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care. Learning Objectives Upon completion of this activity, participants will be able to: 1. Describe the potential benefits and harms associated with prostate cancer screening, as reviewed in commentaries discussing the US Preventive Services Task Force draft statement on prostate cancer screening. 2. 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This controversial conclusion was based on the USPSTF determination that benefits of prostate-specific antigen (PSA)–based screening for prostate cancer were outweighed by harms across the population of screened men. The public comment period mandated by the USPSTF process has recently ended, and thousands of submitted comments are currently under USPSTF review before the final recommendation is published. Four commentaries reviewed the USPSTF draft statement and its underlying evidence base. Study Synopsis and Perspective The debate about PSA screening for prostate cancer, which has reached a crescendo in recent months after the USPSTF recommended against it, continues now in a series of opinion articles published in the December 28 issue of JAMA. Most of the commentators take issue with recommendation. Although the USPSTF "deserves credit for sharpening the focus on the risks and harms of prostate screening," the committee did not get it quite right, suggests an opinion piece from Robert Volk, PhD, from the Department of General Internal Medicine at the University of Texas M.D. Anderson Cancer Center in Houston, and Anthony Wolf, MD, from the Department of Medicine at the University of Virginia School of Medicine in Charlottesville. This was a grade D recommendation, which indicates that physicians have no obligation to mention the issue of prostate cancer screening because testing of asymptomatic men should not occur, the commentators point out. It would be better to have a grade C recommendation, which also recommends against routine screening but would allow for individualized decision making, they note. This would permit physicians to apprise men of the potential benefits and harms of screening, and then the patient and physicians could decide in partnership whether or not to proceed. A grade C recommendation would have put the USPSTF in line with virtually all other medical organizations, including the American Cancer Society and the American Urological Association, in recommending against routine screening but promoting actively engaging men in the decision, Dr. Volk and Dr. Wolf comment. Cannot Go Uncontested http://www.medscape.org/viewarticle/756632_print 1/23/2012 Debate Persists Regarding PSA Screening for Prostate Cancer (printer-friendly) Page 4 of 7 The USPSTF recommendations "miss the mark," according to another set of authors, David Miller, MD, MPH, and Brent Hollenbeck, MD, both from the Department of Urology at the University of Michigan, Ann Arbor. They point out that during the last 2 decades, and concurrent with the dissemination of PSA screening, there has been a significant decline in prostate cancer–specific mortality in the United States (Lancet Oncol. 2008;9:445-452). "This well-established epidemiological trend is difficult, if not impossible, to explain without accepting that early detection strategies built around PSA screening have allowed the identification and successful treatment of patients who would have otherwise died of biologically aggressive, clinically significant prostate cancers," they write. "[T]his advance apparently was barely recognized in the deliberations and communications from the task force," they comment. However well-intentioned, the USPSTF recommendation against PSA screening cannot go uncontested, say Dr. Miller and Dr. Hollenbeck. Although emphasizing the need to avoid harm associated with detection and treatment, which is without question a laudable goal, the task force is essentially "relegating some men to an avoidable death from prostate cancer, including the morbidity associated with metastatic disease." "Clinicians must preserve the ability to detect aggressive prostate cancer while these tumors are still at an early stage," they write. "At the present time, PSA screening is the best tool available to achieve this objective, even if it means some men may experience morbidity and mortality associated with diagnosis and treatment." Change in Management Eliminating PSA-based screening is premature, write Jeri Kim, MD, from the Department of Genitourinary Medical Oncology, and John Davis, MD, from the Department of Urology, University of Texas M.D. Anderson Cancer Center, in a third commentary. "Until each man's risk for prostate cancer can be individually assessed (as it will be in the future), a new model is needed for managing the disease in PSA-screened men, " they write. They suggest changes at the low-grade-disease end of the spectrum, as this is where the problem of overdiagnosis and overtreatment occurs. Low-risk patients could be managed with active surveillance, and some could be treated with 5-alpha reductase inhibitors finasteride and dutasteride. At present, in the United States, about 90% of men with localized disease (including about 75% with lower-risk cancers) undergo surgery or radiation therapy, according to another commentary by Robert Chou, MD, from Oregon Health & Sciences University, Portland, and Michael LeFevre, MD, from the University of Missouri School of Medicine in Columbia. They note that those estimates are based on actual US data (J Clin Oncol. 2010;28:11171123), and whether these rates can be substantially reduced in practice has "yet to be determined." The controversies behind prostate cancer screening may never be fully resolved, they comment, but they, and many of the other authors, emphasize that "[n]o man should be screened without his explicit consent." The Right Call One of the opinion pieces supports the USPSTF recommendation against PSA screening and comes, unsurprisingly enough, considering his well-known stance on cancer screening, from H. Gilbert Welch, MD, MPH, from the Dartmouth Institute for Health Policy & Clinical Practice, Hanover, New Hampshire. (Dr. Welch is author of Should I Be Tested for Cancer? Maybe Not and Here's Why, and a coauthor of Overdiagnosed: Making People Sick in the Pursuit of Health). http://www.medscape.org/viewarticle/756632_print 1/23/2012 Debate Persists Regarding PSA Screening for Prostate Cancer (printer-friendly) Page 5 of 7 "If I was pressed to get off the fence, it's the call I would have made," he writes. "The United States now needs the medical profession to make more calls like this," he writes. "[T]he nation also needs the profession to communicate the nuances of medicine. Most tests and treatment are neither unambiguously good nor unambiguously bad. Instead, their effect is modified by how they are used." Dr. Wolf served as a chair to the American Cancer Society Prostate Cancer Advisory Committee when it developed its 2010 prostate screening guideline, and Dr. Volk served as a consultant to that committee. Dr. Miller is a member of the National Comprehensive Cancer Network Prostate Cancer Treatment Guidelines Committee. Dr. Kim reports receiving research support from Merck. Dr. Davis has acted as a consultant to Baxter and has grants pending with Genprobe and Jansen. Dr. Chou was lead author on the evidence review commissioned by the USPSTF on prostate cancer screening. Dr. LeFevre is the co–vice chair of the USPSTF. JAMA. 2011;306:2715-2722, 2649-2650. Volk and Wolf extract, Kim and Davis extract, Miller and Hollenbeck extract, Chou and LeFevre extract, Welch extract Study Highlights • The main benefit evaluated by USPSTF was prostate cancer–specific mortality in 2 trials: the European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. • In ERSPC, screening was associated with a decreased absolute risk for prostate cancer mortality of 0.6 per 1000 men during a median follow-up of 8.8 years. However, in PLCO, screening was associated with an increased absolute risk of 0.2 per 1000 men during a median follow-up of 6.3 years. • These results appeared to be conflicting; there were methodologic issues in both trials, and neither difference was statistically significant. • In a prespecified subgroup of men 55 to 69 years old enrolled in ERSPC, there was a statistically significant absolute reduction in the risk for prostate cancer mortality of 0.7 per 1000 men. The number needed to invite to screening was 1410 to prevent 1 prostate cancer death. • The commentary by Chou and LeFevre noted that effects of screening on prostate cancer mortality might increase with longer follow-up, or that competing mortality could lessen the possibility of additional benefits. • Surgery and radiation therapy used to treat localized prostate cancer are associated with important and frequent harms, including perioperative death, cardiovascular complications, urinary incontinence, and erectile dysfunction. • Chou and LeFevre recommend that no man be screened without his explicit consent, and that clinicians and health systems performing screening should demonstrate that they can, in fact, reduce avoidable harms by being more selective about use of potentially curative treatments in patients with low-risk prostate cancers. • The commentary by Kim and Davis recommends a patient-specific approach to prostate cancer screening, noting that the USPSTF draft statement conflicts with the preferences of individual patients and with future developments in the postgenomic era. • As genomics and proteomics become integrated into individual risk assessments based on tumor aggressiveness and life expectancy, clinicians may determine personalized prevention and management strategies from molecular risk profiles. • The commentary by Miller and Hollenbeck disagrees with the USPSTF recommendation against screening, stating that eliminating PSA as a screening tool will not result in meaningful progress in treating men with prostate cancer. • Instead, these authors recommend further robust efforts to refine current screening practices, increase active surveillance, and improve local treatments that increase survival duration while lowering adverse effects on quality of life. http://www.medscape.org/viewarticle/756632_print 1/23/2012 Debate Persists Regarding PSA Screening for Prostate Cancer (printer-friendly) Page 6 of 7 • In their commentary, Drs. Volk and Wolf note that the crux of the prostate screening controversy is that many men are willing to undergo possible risk and harm if it will avoid death from cancer, whereas many other men are not. • Their proposed solution is to engage men in informed decision making, and they suggest that the USPSTF upgrade the prostate screening recommendation from a "D" to a "C." • Both the D and C grades recommend against routine screening (ie, screening without involving men in the decision), but only the C recommendation allows for individualized decision making. Clinical Implications • Two trials studying the effects of screening on prostate cancer–specific mortality showed conflicting and mostly not statistically significant results, but both trials had methodologic issues. Surgery and radiation therapy used to treat localized prostate cancer are associated with important and frequent harms. • Opinions expressed in 4 commentaries include requiring patient consent for prostate cancer screening, involving the patient in the decision regarding screening, using molecular risk profiles for personalized prevention and management strategies, and upgrading the USPSTF prostate screening recommendation from a "D" to a "C." CME Test To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test. According to 4 commentaries discussing the USPSTF draft statement on prostate cancer screening, which of the following statements about the potential benefits and harms associated with prostate cancer screening is not correct? In men 55 to 69 years old enrolled in ERSPC, there was a statistically significant absolute reduction in the risk for prostate cancer mortality of 0.7 per 1000 men In PLCO, screening was associated with a not statistically significant increased absolute risk of 0.2 per 1000 men Longer follow-up would definitely improve the effects of screening on prostate cancer mortality Harms of prostate cancer treatment may include perioperative death, cardiovascular complications, urinary incontinence, and erectile dysfunction According to 4 commentaries discussing the USPSTF draft statement on prostate cancer screening, which of the following opinions about the clinical implications of proposed changes to the USPSTF draft statement on prostate cancer screening is most likely correct? Screening may be done without explicit patient consent Being more selective about use of potentially curative treatments in patients with low-risk prostate cancers may reduce potential harms Screening strategies should apply universally to all men The C grade does not recommend against routine screening Save and Proceed http://www.medscape.org/viewarticle/756632_print 1/23/2012 Debate Persists Regarding PSA Screening for Prostate Cancer (printer-friendly) Page 7 of 7 This article is a CME/CE certified activity. To earn credit for this activity visit: http://www.medscape.org/viewarticle/756632 Medscape Education © 2012 Medscape, LLC Disclaimer The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on www.medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity. This article is a CME/CE certified activity. To earn credit for this activity visit: http://www.medscape.org/viewarticle/756632 http://www.medscape.org/viewarticle/756632_print 1/23/2012