Overview

Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Status:
Not yet recruiting

Trial end date:
2029-04-01

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC) The main questions it aims to answer are: - Radiological progression-free survival (rPFS) in mCSPC - Overall Survival (OS) - Symptomatic skeletal event-free survival (SSE-FS) - Initiation of subsequent antineoplastic therapy - Safety Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.

Phase:

Phase 3

Details

Lead Sponsor:

GenesisCare USA

Collaborator:

Bayer