ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
This is an open label non-comparative controlled randomized phase II study. The experimental
arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is
included as an internal control.
The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen
(PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in
the range of those achieved with 24 weeks of ADT.
In total, this 1:1 randomized study will therefore require randomization of at least 250
patients, 125 to each arm.
Phase:
Phase 2
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC