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

The purpose of this study is to assess whether six months of daily finasteride (PROSCAR), following an initial negative prostate biopsy, will improve the detection of prostate cancer on repeat biopsy.

144 subjects with an initial negative prostate biopsy will be randomized to receive either finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy following drug intervention. PSA (prostate specific antigen) measurements, testosterone levels, and quality of life questionnaires will also be assessed during the study. The two groups will then be compared.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: Finasteride
  • Finasteride (5mg) will be given once per day for 6 months.
• Drug: Placebo
  • Placebo will be given once a day for 6 months.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• The rate of prostate cancer at repeat TRUS (Transrectal Ultrasound) guided biopsy after 6 months of therapy with Finasteride/placebo.
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Change in PSA parameters over time: a. PSA velocity b. PSA density c. Free/total PSA
  • Time Frame: 6 months
    Safety Issue?: No
• TRUS at baseline and at the 6-month biopsy will be used to measure the total gland and transition zone volumes.
  • Time Frame: 6 months
    Safety Issue?: No
• TRUS nodule detection/visibility
  • Time Frame: 6 months
    Safety Issue?: No
• Prostate vascularity as detected by Doppler ultrasound
  • Time Frame: 6 months
    Safety Issue?: No
• Quality of life as tested by the IPSS (International Prostate Symptom Score)
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Initial biopsy, performed at UHN, of at least 8 cores with no evidence of cancer (HGPIN or ASAP allowed)
• PSA < 20ng/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 subject.
• Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to finasteride.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Health Network, Toronto

Overall Clinical Trial Officials and Contacts

Antonio Finelli, MD MSc FRCSC Principal Investigator University Health Network, Toronto  

Overall Contact: Keri L Durrant, BSc. 416-946-4501 keri.durrant@uhn.on.ca

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542243

Study ID Number: 07-0499-B

ClinicalTrials.gov Identifier: NCT00542243

Health Authority: Canada: Health Canada