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

NCT00553878 | Completed Phase 2 DMC

• 1 other identifier: CURC/CUOG-AVIAS-0601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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

  2 Years

Study Arms (1)

dutasteride

PLACEBO COMPARATOR

Drug: Dutasteride

Interventions

Dutasteride DRUG

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

Also known as: placebo

dutasteride

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Urology Research Consortium: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Laurence Klotz, MD

  CURC

  PRINCIPAL INVESTIGATOR

• Larry S Goldeng

  CUOG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2012
• Last Updated: October 14, 2016

Record last verified: 2012-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)