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

Phase 3
18 Years
Open (Enrolling)
Enlarged Prostate

Thank you

Trial Information

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

The rate of prostate cancer at repeat TRUS (Transrectal Ultrasound) guided biopsy after 6 months of therapy with Finasteride/placebo.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Antonio Finelli, MD MSc FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

February 2008

Completion Date:

January 2012

Related Keywords:

  • Enlarged Prostate
  • enlarged prostate
  • finasteride