Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Dutasteride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: dutasteride<br> | Drug: Dutasteride<br>* dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 Years |