Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
Information source: Canadian Urology Research Consortium
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Dutasteride (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Canadian Urology Research Consortium Official(s) and/or principal investigator(s):
Laurence Klotz, MD, Principal Investigator, Affiliation: CURC
Larry S Goldeng, Principal Investigator, Affiliation: CUOG
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: 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
Detailed 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.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Additional Information
Starting date: March 2007
Last updated: July 31, 2012
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