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

Sponsor
Canadian Urology Research Consortium (Other)
Overall Status
Completed
CT.gov ID
NCT00553878
Collaborator
GlaxoSmithKline (Industry)
100
Enrollment
1
Location
1
Arm
69.1
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
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 Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: dutasteride

Drug: Dutasteride
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Canadian Urology Research Consortium
    • GlaxoSmithKline

    Investigators

    • Principal Investigator: Laurence Klotz, MD, CURC
    • Principal Investigator: Larry S Goldeng, CUOG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Canadian Urology Research Consortium
    ClinicalTrials.gov Identifier:
    NCT00553878
    Other Study ID Numbers:
    • CURC/CUOG-AVIAS-0601
    • NCT00516815
    First Posted:
    Nov 6, 2007
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    Dec 1, 2012
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Dutasteride

    Study Results

    No Results Posted as of Oct 14, 2016