Prostate Cancer Prevention Trial (PCPT) update

The Prostate Cancer Prevention Trial is an intergroup effort in the USA man aged by the Southwest Oncology Group (SWOG) in collaboration with the Easte rn Cooperative Oncology Group (ECOG) and the Cancer and Leukemia Group B (C ALGB). This 10-year study began approximately 5 years ago and will achieve its primary endpoint in October 2004. At the start of the study, 18,882 men , aged over 55 years, and with normal digital rectal examination (DRE) and serum prostate-specific antigen (PSA) levels of less than or equal to 3.0 n g/ml were randomized to take finasteride (5 mg/day) or placebo (1 tablet/da y). DRE and PSA have been determined yearly (PSA in a central laboratory). When DRE is abnormal or PSA rises to >4.0 ng/ml, a biopsy is recommended. B ecause of the effect finasteride has on PSA, the PSA value has been indexed to equalize the number of biopsies in both arms. At 7 years all survivors will undergo a sextant biopsy to determine the period prevalence of prostat e cancer. The critical assumptions are: (1) finasteride-induced PSA changes result in a simple downward shift; (2) the assessment of adherence is sens itive enough to detect nonadherence affecting PSA level interpretation: (3) factors affecting biopsy loss will be equal in both arms; (4) finasteride does not affect the sensitivity or specificity of DRE on transrectal ultras ound nor the sensitivity of biopsy; (5) bias resulting from transurethral r esection of the prostate in benign prostate hyperplasia cases will be negli gible.