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While the professional community continues to debate the efficacy of prostate cancer screening, thousands of asymptomatic men in the United States receive screening in free programs held each September during Prostate Cancer Awareness Week (1). However, many men who seek prostate cancer screening do not understand the limitations of screening or the medical community’s disagreements on whether screening reduces prostate cancer mortality and whether it leads to overdiagnosis (2–4). Because the efficacy of prostate cancer screening will not be known for at least 5 years (5), men need to have balanced information about its potential benefits and limitations. As part of a larger study concerning the development and evaluation of a print-based decision aid for participants in free screening programs, we conducted an informal survey of all 39 National Cancer Institute (NCI)–designated comprehensive cancer centers and all 11 NCI-designated clinical cancer centers from October through December 2003. We sought to determine whether cancer centers that conduct free prostate cancer screening programs provide men with consent forms and educational materials that address the uncertainties surrounding screening. We found that 14 of the comprehensive cancer centers and three of the clinical cancer centers currently provide a free annual prostate cancer screening program. Of the 17 current programs, 14 (82%) used informed consent documents. Of these, only six consent forms (43%) contained information describing the uncertainty of whether screening reduces prostate cancer mortality. In addition, the consent forms contained information about the following topics: prostate-specific antigen test limitations (n 8 [57%]; e.g., discomfort of the needle stick, possibility of infection), digital rectal examination limitations (n 9 [64%]; e.g., discomfort, rectal bleeding), the need for follow-up testing in the event of an abnormal result (n 13 [93%], although only two [14%] specifically mentioned the possibility of a biopsy), the possibility of false-positive results (n 9 [64%]), and the possibility of false-negative results (n 6 [43%]). Regarding educational materials, 15 of the screening programs provided booklets containing general information about prostate health, screening, and/or cancer. Materials were typically displayed on tables and were not systematically distributed to each participant. Five centers (33%) provided materials that mentioned the uncertainties about prostate cancer screening [e.g., the NCI’s “Questions and Answers About the Prostate-Specific Antigen Test” (6) and the American Cancer Society/National Comprehensive Cancer Network’s “Prostate Cancer Treatment Guidelines for Patients” (7)]. The materials provided by eight centers (53%) did not mention the controversy, and the content of the materials provided by two centers (14%) was unknown (the materials were unspecified pharmaceutical company brochures). From this informal survey, we learned that fewer than half of the consent forms addressed the issue of whether screening reduces diseaserelated mortality. Until definitive data demonstrate the effectiveness of prostate cancer screening, ensuring that men understand the potential benefits and the potential limitations of screening is of the utmost importance. Most participants in mass screening programs do not provide informed consent for screening, because the most widely used consent forms do not provide the complete information necessary for truly informed consent. We suggest that, at a minimum, consent forms state that research has not yet definitively shown that prostate cancer screening reduces disease-related mortality and that not all doctors agree that men should be screened. Even with this addition, it may remain difficult for men to understand the complex issues surrounding prostate cancer screening, particularly for men who have already made a commitment to undergo screening. Thus, we assert that educating men in advance of the screening appointment, when the time and resources to understand this complex information are available, would increase the likelihood of men making informed decisions. Prostate cancer screening is a classic case of technology preceding the availability of effectiveness data, and NCI-designated cancer centers have a particular obligation to educate men about the current state of the science to help men make the best decision for themselves.

Prostate Cancer Screening at National Cancer Institute Comprehensive and Clinical Cancer Centers