NCT00553878

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Canadian Urology Research Consortium · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dutasteride	dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-09-01
• Completion: 2012-12-01
• First posted: 2007-11-06
• Last updated: 2016-10-14

Locations

1 site across 1 country: Canada