ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

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.

NCT Number	NCT02972060
Lead Sponsor	European Organisation for Research and Treatment of Cancer - EORTC Collaborators: Bayer
Conditions	Prostate Cancer
Enrollment	61 participants
Start Date	2017-12-01
Primary Completion	2023-01-13 (estimated)
Study Completion	2036-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-19