drugset / Trial / NCT04237584
A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
Phase 3
Terminated
23 enrolled
MANA RBM
Barbara Ann Karmanos Cancer Institute · collabBayer · collabCarolina Urologic Research Center · collabTulane University · collab
RandomizedSequentialDouble-blindTreatment
Summary
This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo.
Timeline
- Start
- 2020-06-30
- Primary completion
- 2022-03-07
- Completion
- 2022-03-07
Outcome
Met primary endpoint
Stopped (Enrollment): “The study was stopped due to insurmountable enrollment challenges affecting trial accrual, resulting from the rapidly evolving treatment options for advanced prostate cancer.”
release “The EORTC PEACE III study evaluating radium-223 dichloride (Xofigo™) in combination with enzalutamide met its primary endpoint of improved and demonstrated overall survival (OS).” bayer.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 300 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Comparator | Radium-223 | Other / unclassified | 0.055 mbq/kg | Intravenous |