drugset / Trial / NCT00558363

ARTS - AVODART After Radical Therapy For Prostate Cancer Study

NCT00558363 ↗

Phase 2 Completed 294 enrolled GlaxoSmithKline
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-11
Primary completion
2010-12
Completion
2011-03

Outcome

Met primary endpoint

paper Dutasteride significantly delayed the time to PSA doubling compared with placebo after 24 mo of treatment (p<0.001); PMID 23176897 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dutasteride Small molecule 0.5 mg Oral

Indications