A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies
- Initial biopsy, performed at UHN, of at least 8 cores with no evidence of cancer
(HGPIN or ASAP allowed)
- PSA < 20 ng/ml
- 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.
- Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior
to visit one.
- Concurrent and previous use within the past 12 months of the following medications:
Finasteride (PROSCAR, Propecia), Dutasteride (Avodart), Any other investigational 5
alpha-reductase inhibitors, Anabolic steroids, drugs with antiandrogenic properties.
- Participation in an 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, aspartate aminotransferase, or alkaline phosphatase; or
bilirubin > 1.5 times the upper limit of normal.
- Serum creatinine > 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
- Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically
related to finasteride.