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

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.

Timeline

Start

2023-09

Primary completion

2028-12

Completion

2029-04

Drugs

Indications