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Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer


Phase 2/Phase 3
45 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Multi Center Double Blind Study Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Laurence Klotz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CURC

Authority:

Canada: Health Canada

Study ID:

CURC/CUOG-AVIAS-0601

NCT ID:

NCT00553878

Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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