Clinical trial NCT00553878: Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: Canadian Urology Research Consortium
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-11-06
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
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
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: CURC
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CUOG
name: Larry S Goldeng
role: PRINCIPAL_INVESTIGATOR
References: