Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer (AVIAS)
This study is ongoing, but not recruiting participants.
Sponsor:
Canadian Urology Research Consortium
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT00553878
First received: November 5, 2007
Last updated: July 31, 2012
Last verified: December 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Dutasteride |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) 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 |
Resource links provided by NLM:
Further study details as provided by Canadian Urology Research Consortium:
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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: dutasteride |
Drug: Dutasteride
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Other Name: placebo
|
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| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553878
Locations
| Canada, Ontario | |
| 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 |
More Information
No publications provided
| Responsible Party: | Canadian Urology Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00553878 History of Changes |
| Obsolete Identifiers: | NCT00516815 |
| Other Study ID Numbers: | CURC/CUOG-AVIAS-0601 |
| Study First Received: | November 5, 2007 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens |
Dutasteride Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013