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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553878
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):
Canadian Urology Research Consortium

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Dutasteride Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : March 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Dutasteride

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553878

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Canadian Urology Research Consortium
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Principal Investigator: Laurence Klotz, MD CURC
Principal Investigator: Larry S Goldeng CUOG
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Responsible Party: Canadian Urology Research Consortium Identifier: NCT00553878    
Obsolete Identifiers: NCT00516815
Other Study ID Numbers: CURC/CUOG-AVIAS-0601
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: December 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: plan to share in publication
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs