TREATMENT WITH FINASTERIDE PRESERVES USEFULNESS OF PROSTATE-SPECIFIC ANTIGEN IN THE DETECTION OF PROSTATE-CANCER - RESULTS OF A RANDOMIZED,DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objectives, To evaluate prostate cancer detection and prostate-specifi c antigen (PSA) among men with benign prostatic hyperplasia treated wi th finasteride. Methods, Three thousand forty men 45 to 78 years of ag e with PSA less than 10 ng/mL and no history of prostate cancer were r andomized in a double-blind, placebo-controlled trial to finasteride ( n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98% of patients wi th a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy wa s requested of all such patients without a recent second negative biop sy or a prostate cancer diagnosis. Results. Overall, 644 patients (21% ) underwent biopsy and 201 (6.6%) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7% of men on finaste ride and 5.1% on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35% of cases on finasteride and 34% on placebo. The area under the re ceiver operating characteristic curve for last PSA was 0.84 on finaste ride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal f or last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yie lded similar sensitivity (66% versus 70%, P = 0.6), higher specificity (82% versus 74%, P < 0.0001), and a higher likelihood ratio (3.6 vers us 2.7, P < 0.05) for finasteride than for placebo. Conclusions, In me n treated with finasteride, multiplying PSA by 2 and using normal rang es for untreated men preserves the usefulness of PSA for prostate canc er detection. UROLOGY 52: 195-202, 1998. (C) 1998, Elsevier Science In c. All rights reserved.