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

NCT ID: NCT00553878

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dutasteride

Group Type: PLACEBO_COMPARATOR

Dutasteride

Intervention Type: DRUG

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

Interventions

Dutasteride

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

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Canadian Urology Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Klotz, MD

Role: PRINCIPAL_INVESTIGATOR

CURC

Larry S Goldeng

Role: PRINCIPAL_INVESTIGATOR

CUOG

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CURC/CUOG-AVIAS-0601

Identifier Type: -

Identifier Source: org_study_id

NCT00516815

Identifier Type: -

Identifier Source: nct_alias