At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men With Prostate Cancer and Biochemical Failure (PSA Increase) After Radical Therapy With Curative Intent
In Brief
A Phase 2 clinical trial evaluating Avodart and placebo for Neoplasms, Prostate and Prostate Cancer After a Radical Treatment. Completed, enrolled 294 participants across 66 sites in 9 countries.
Detailed Summary
ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.
Study Details
Timeline
Interventions
0.5 mg administered orally once daily
Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo