A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies

Condition(s) targeted: Prostate Cancer

Intervention: finasteride (Drug); Comparator: placebo (unspecified) (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Twenty percent of men with an initial negative prostate biopsy are found to have cancer on a repeat biopsy. finasteride (a 5-ARI) reduces prostate volume and improves the utility of PSA and DRE. thus, six months of finasteride may improve the detection rate of prostate cancer in men with an initial negative biopsy.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Proscar in Men With Initial Negative Prostate Biopsies

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Primary outcome: The rate of prostate cancer at repeat trus guided biopsy after 6 months of therapy

Secondary outcome:

Change in psa parameters over time

TRUS at baseline and at the 6-month biopsy will be used to measure the total gland and transition zone volumes

TRUS nodule detection/visibility: measured at baseline and 6 months

Prostate vascularity as detected by doppler ultrasound: measured at baseline and 6 months

Quality of life as tested by IPSS; a 4-point change on a 35 points scale is considered clinically significant

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: Initial biopsy, performed at UHN, of at least 8 cores with no evidence of cancer (HGPIN or ASAP followed) PSA less or equal to 20ng/ml Prostate volume greater or equal to 25cc and less or equal to 81cc Able to swallow and retain oral medication Able to read and write (IPSS questionnaire is self-administered), understand instructions related to study procedures and to give written informed consent Exclusion Criteria: Glucocorticosteroids, except inhaled or topical, are not permitted within 3 months prior to visit 1 concurrent and previous use within the past 12 months of the following medications: finasteride (proscar, propecia) dutasteride (gi198745, avodart) any other investigational 5a-reductase   inhibitors anabolic steroids drugs with antiandrogenic properties (e. g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents) Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP); or bilirubin greater than 1. 5 times the upper limit of normal Serum creatinine greater than 1. 5 times the upper limit of normal Any unstable serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject Known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to proscar

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Francois Bertrand, Dr., Phone: 1-514-428-2641

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: December 2007
Ending date: December 2009
Last updated: December 24, 2007