title: Clinical experience of the detection of prostate cancer in patients with benign prostate hyperplasia treated with finasteride. The Finasteride Study Group.
abstract: The clinical experience relating to the detection of prostate cancer in patients participating in 2 large multicenter clinical trials of finasteride in the treatment of benign prostatic hyperplasia is reviewed. A total of 1,645 patients 40 to 83 years old with benign prostatic hyperplasia 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 finasteride 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. Patients with a prostate specific antigen level of 40 ng/ml or more, or any finding suggestive of prostate cancer were excluded. During the study period 32 cases of prostate cancer were diagnosed: 12 were detected during the 12 months of the controlled study and were evenly distributed 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. From these results we conclude that finasteride-treated patients should be evaluated periodically by digital rectal examination, careful monitoring of prostate specific antigen levels and appropriate investigation of any suspicious findings.
authors.affiliation: Merck Research Laboratories, Rahway, New Jersey.
authors.forename: E
authors.initials: E
authors.lastname: Stoner
authors.forename: E
authors.initials: E
authors.lastname: Round
authors.forename: D
authors.initials: D
authors.lastname: Ferguson
authors.forename: G J
authors.initials: GJ
authors.lastname: Gormley
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010173:Palpation; D017430:Prostate-Specific Antigen / Q000032:analysis; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011471:Prostatic Neoplasms / Q000150:complications / Q000175:diagnosis*
chemical_list: D018120:Finasteride; D017430:Prostate-Specific Antigen