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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014