CLINICAL-EXPERIENCE OF THE DETECTION OF PROSTATE-CANCER IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA TREATED WITH FINASTERIDE

The clinical experience relating to the detection of prostate cancer i n patients participating in 2 large multicenter clinical trials of fin asteride in the treatment of benign prostatic hyperplasia is reviewed. A total of 1,645 patients 40 to 83 years old with benign prostatic hy perplasia was randomized to receive 1 or 5 mg. finasteride or placebo once a day for 12 months in a double-blind fashion followed by an open extension study in which all patients were treated with 5 mg. finaste ride daily. At entry, all patients were to have a maximum urinary flow rate of 15 ml. per second or less with a voided volume of 150 ml. or more, an enlarged prostate and symptoms of urinary obstruction. Patien ts with a prostate specific antigen level of 40 ng./ml. or more, or an y finding suggestive of prostate cancer were excluded. During the stud y period 32 cases of prostate cancer were diagnosed: 12 were detected during the 12 months of the controlled study and were evenly distribut ed among the treatment groups (4 on placebo, and 3 on 1 mg. and 5 on 5 mg. finasteride) and 20 cases were detected in the extension study. F rom these results we conclude that finasteride-treated patients should be evaluated periodically by digital rectal examination, careful moni toring of prostate specific antigen levels and appropriate investigati on of any suspicious findings.