Estimated impact of the Prostate Cancer Prevention Trial on population mortality

BACKGROUND The potential public health impact of the recently completed Prostate Cancer Prevention Trial (PCPT) is debated. The results indicated that the period prevalence of prostate cancer was reduced by 24.8% due to finasteride, whereas an increase in the rate of high‐grade tumors (Gleason score 8–10) among men who were diagnosed with cancer also was found (5.0% in the PCPT placebo arm vs. 11.9% in the PCPT finasteride arm). Whether the increased Gleason score was valid or was a histologic artifact is under investigation. METHODS The authors estimated the number of person‐years saved assuming a 24.8% reduction in the incidence of prostate cancer for 5 years among United States males age ≥ 55 years. Scenarios for different proportions of patients with high‐grade Gleason scores also were considered. RESULTS With a 24.8% reduction in the number of men with newly diagnosed prostate cancer, the authors estimated that 316,760 person‐years would be saved due to finasteride in the United States. An absolute increase of 6.9% in the proportion of men with high‐grade tumors in the United States cancer population (corresponding to the difference between the rates on the placebo and finasteride arms of the PCPT) would reduce the number of person‐years saved to 262,567. For each absolute increase of 5% in the proportion of patients with high‐grade tumors, the number of person‐years saved would be reduced by approximately 39,000. CONCLUSIONS The results of the PCPT may have a major impact on population mortality from prostate cancer if they are applied clinically. The potential detrimental effects of an increased rate of patients who have prostate cancer with high‐grade Gleason scores would be outweighed by a reduction in incidence. Cancer 2005. © 2005 American Cancer Society. The results of the Prostate Cancer Prevention Trial, which showed a reduction in the period prevalence of prostate cancer but also showed an increase in the rate of high‐grade prostate cancers, sparked debate regarding the potential public health impact of finasteride. In the current analysis, the authors showed that finasteride may have a major impact on population mortality from prostate cancer if it is applied clinically and that the potential detrimental effects of an increased rate of patients with high‐grade Gleason score would be outweighed by a reduction in incidence.