Last reviewed · How we verify
A Phase III Randomized Study Comparing the Combination of Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With Metastatic Castration-Sensitive Prostrate Cancer (mCSPC) (CARE)
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.
Details
| Lead sponsor | GenesisCare USA |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2023-09 |
| Completion | 2029-04 |
Conditions
- Metastatic Prostate Cancer
Interventions
- Darolutamide
- Radium-223
Primary outcomes
- Radiological progression-free survival (rPFS) in mCSPC patients — First occurrence bone scan progression and/or soft tissue progression per #RECIST 1.1 criteria, participant dies, withdraws consent and/or study is terminated, whichever comes first.
The primary objective of this study is to compare the radiological progression-free survival (rPFS) in mCSPC patients treated with darolutamide plus radium-223 versus darolutamide plus placebo. The primary endpoint is radiological progression-free survival rPFS, defined as time to first occurrence of 99mTc MDP+ bone scan progression per PCWG3 criteria, and/or soft tissue progression by CT/MRI per PCWG3 modifications to RECIST 1.1 criteria, or death from any cause. Randomization will be stratified by ECOG performance status 0 vs 1-2, and metastatic disease status, specifically low volume (\<4 bone lesions) versus high volume (≥4 bone lesions).