A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy (Prostress)
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|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Finasteride
The recommended dosage of PROSCAR© is one 5 mg tablet daily with or without food. If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual.
PROSCAR© 5 mg tablets are blue, apple-shaped; film coated with the code MSD 72 on one side and PROSCAR on the other. They will be provided in bottles of 35 tablets.
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.
5.0. Study Design and Treatment 5.1. Study Design This is a randomized, two-arm, double blind, placebo controlled study of daily PROSCAR® or placebo for 6 months in men with an initial negative prostate biopsy.
5.1.1. Biopsy The TRUS guided biopsy, to be carried out at Visit 4, will be performed by one physician. The biopsy will be performed as per the standard protocol at UHN, including 13-15 cores. The physician performing the biopsy will be blinded to the initial biopsy results and the PSA change over time. Before biopsy, a DRE will be performed. Aside from the standard biopsy scheme, suspicious areas on TRUS can be further biopsied. (e.g. a hypoechoic nodule).
5.2. Methods for Accrual and Randomization: Patients with an initial negative prostate biopsy that was performed at UHN and seen at the Prostate Center of the Princess Margaret Hospital will be considered for enrolment. Randomization by a random numbers table will be performed in blocks of 4 patients. After patients are deemed eligible for the study, the central office at Merck will be contacted and patient assignment given. The code will match the study drug label and the drug shipment will contain a blinded allocation envelope. The investigators, study participants and research coordinators will be blinded to the intervention.
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Antonio Finelli, MD MSc FRCSC||University Health Network, Toronto|