Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||Canadian Urology Research Consortium|
|Start date||March 2007|
|End date||September 2009|
|Trial size||100 participants|
|Trial identifier||NCT00553878, CURC/CUOG-AVIAS-0601, NCT00516815|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver)|
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
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.
|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.|
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