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

Prostate Cancer Clinical Trial

— AVIAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553878
• Other study ID #: CURC/CUOG-AVIAS-0601
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 5, 2007
• Last updated: October 13, 2016
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Canadian Urology Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00516815

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Urology Research Consortium	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 Years	No