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

October 13, 2016 updated by: Canadian Urology Research Consortium

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Urology Research Consortium

Collaborators

GlaxoSmithKline

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURC/CUOG-AVIAS-0601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

plan to share in publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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