A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy (Prostress)
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies|
- The rate of prostate cancer at repeat TRUS (Transrectal Ultrasound) guided biopsy after 6 months of therapy with Finasteride/placebo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in PSA parameters over time: a. PSA velocity b. PSA density c. Free/total PSA. [ Time Frame: 6 months ] [ Designated as 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 ] [ Designated as safety issue: No ]
- TRUS nodule detection/visibility. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Prostate vascularity as detected by Doppler ultrasound. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life as tested by the IPSS (International Prostate Symptom Score). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Finasteride||
Finasteride (5mg) will be given once per day for 6 months.
Other Name: PROSCAR
Placebo Comparator: Placebo
Patient will receive a placebo comparator each day for 6 months.
Placebo will be given once a day for 6 months.
|Contact: Keri L Durrant, BSc., PGCR, CCRP||416-946-4501 ext firstname.lastname@example.org|
|Contact: Hersey Karen, RNemail@example.com|
|University Health Network, Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Antonio Finelli, MD MSc FRCSC||University Health Network, Toronto|