NCT00558363

ARTS - AVODART After Radical Therapy For Prostate Cancer Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 (ARTS - AVODART after Radical Therapy for prostate cancer Study)

Conditions

• Neoplasms, Prostate
• Prostate Cancer After a Radical Treatment

Interventions

Type	Name	Description
DRUG	Avodart	0.5 mg administered orally once daily
OTHER	placebo	Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2007-11-14
• Last updated: 2012-03-21
• Results posted: 2011-12-13

Locations

66 sites across 9 countries: Estonia, Finland, France, Germany, Netherlands, Russia, Spain, Sweden, United Kingdom