- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00553878
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
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
-
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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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
|
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Other Names:
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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.
Collaborators
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
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 5-alpha Reductase Inhibitors
- Dutasteride
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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