A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Lead-in open-label androgen-receptor blocker (ARB) followed by double-blind Radium-223 or placebo.Masking: Double (Participant, Investigator)Masking Description: Masking of Radium-223 or placebo onlyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The hypothesis investigators will test in this study is whether layering radium-223 following 16 weeks of enzalutamide or darolutamide exposure in patients demonstrating a biochemical response improves disease outcomes. By adding radium-223 following a potential bone flare phenomenon [after first 12...
The hypothesis investigators will test in this study is whether layering radium-223 following 16 weeks of enzalutamide or darolutamide exposure in patients demonstrating a biochemical response improves disease outcomes. By adding radium-223 following a potential bone flare phenomenon [after first 12-14 weeks of therapy with an androgen receptor blocker (ARB)], including patients expected to have durable response to systemic therapy, and mandating the use of bone protective agents during treatment, the investigators aim to demonstrate an optimal time to add radium-223 in the mCRPC landscape.
Tracking Information
- NCT #
- NCT04237584
- Collaborators
- Bayer
- Carolina Urologic Research Center
- Tulane University
- Barbara Ann Karmanos Cancer Institute
- Investigators
- Study Chair: Neal Shore, MD Carolina Urologic Research Center
Get Well Soon