Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment dutasteride
Phase phase 2/phase 3
Sponsor Canadian Urology Research Consortium
Collaborator GlaxoSmithKline
Start date March 2007
End date September 2009
Trial size 100 participants
Trial identifier NCT00553878, CURC/CUOG-AVIAS-0601, NCT00516815

Summary

Patient on an intermittent androgen deprivation protocol for biochemical recurrence after radical local therapy for prostate cancer,the addition of continuous dutasteride treatment, significantly prolongs the duration of the off treatment interval and time to androgen independence.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Placebo Comparator)
dutasteride placebo
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval

Primary Outcomes

Measure
To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
time frame: 2 Years

Eligibility Criteria

Male participants from 45 years up to 80 years old.

Inclusion Criteria: - Able to give informed consent - Age_>45and<_80 - Histological confirmed adenocarcinoma of prostate - Has received external beam radiation,brachytherapy or radical prostatectomy for the treatment of prostate ca - Candidate for intermittent androgen ablation - Minimum of 3 PSA values above nadir taken at least 1 month apart - Serum testosterone >_250ng/dl,ECOG 0 or 1 - Negative bone scan within 12 months of visit 1 - Able to swallow and retain oral medication Exclusion Criteria: - Previous treatment with chemotherapy - Hormonal therapy with in last year - Glucocorticoid with in last 3 months - LHRH analogues with in previous year - Ketoconazole - Non Steroidal anti-androgens with in previous year - Concurrent or previous use of Finasteride Dutasteride 5a reductase inhibitor anabolic steroids - Over the counter or herbal prep such as saw palmetto selenium or vitamin E within last year - May not be receiving any other investigational drug with in last 30 days - Evidence of distant metastases - Has received adjuvant or neoadjuvant ablation in past 12 months - Unstable serious co-existing medical condition - Abnormal liver and kidney functions - Previous malignancy not including curative treated basal cell carcinoma of skin with in 5 years and bladder cancer with in past 2 years - Known hypersensitivity to any 5a-reductase inhibitor or to any drug chemically related to dutasteride - Known hypersensitivity to bicalutamide.

Additional Information

Official title Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer
Principal investigator Laurence Klotz, MD
Description The study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05 mg on the length of the off treatment interval in men receiving intermittent androgen therapy for localized prostate cancer.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Canadian Urology Research Consortium.