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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Canadian Urology Research Consortium.
Recruitment status was  Active, not recruiting
Sponsor:
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

November 5, 2007
July 31, 2012
March 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
  • prolong the duration of the off treatment interval and possibly increase th duration of androgen dependency [ Time Frame: 24 months ]
  • Serum PSA [ Time Frame: 2 Years ]
Complete list of historical versions of study NCT00553878 on ClinicalTrials.gov Archive Site
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Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Prostate Cancer
Drug: Dutasteride
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Other Name: placebo
Placebo Comparator: dutasteride
Intervention: Drug: Dutasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2012
September 2009   (final data collection date for primary outcome measure)

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.
Male
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00553878
CURC/CUOG-AVIAS-0601
Yes
Canadian Urology Research Consortium
Canadian Urology Research Consortium
GlaxoSmithKline
Principal Investigator: Laurence Klotz, MD CURC
Principal Investigator: Larry S Goldeng CUOG
Canadian Urology Research Consortium
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP