Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer (AVIAS)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dutasteride
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility 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.
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
dutasteride
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00553878
First Posted
November 5, 2007
Last Updated
October 13, 2016
Sponsor
Canadian Urology Research Consortium
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00553878
Brief Title
Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
Acronym
AVIAS
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Urology Research Consortium
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dutasteride
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Other Intervention Name(s)
placebo
Intervention Description
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Klotz, MD
Organizational Affiliation
CURC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry S Goldeng
Organizational Affiliation
CUOG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
plan to share in publication
Learn more about this trial
Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
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