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A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

NCT04237584 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-10-07

Study results available
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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.

Conditions

Interventions

DRUG

Enzalutamide during Lead-in Period

Participants will receive 12 weeks open-label lead-in ARB (enzalutamide) that will continue after double-blind randomization to radium-223 or placebo.

DRUG

Lead-in Enzalutamide followed by Radium-223/Enzalutamide

After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.

DRUG

Lead-in Enzalutamide followed by Placebo/Enzalutamide

After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.

DRUG

Darolutamide during Lead-in Period

Participants will receive 12 weeks open-label lead-in darolutamide that will continue after double-blind randomization to radium-223 or placebo.

DRUG

Lead-in Darolutamide followed by Radium-223/Darolutamide

After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.

DRUG

Lead-in Darolutamide followed by Placebo/Darolutamide

After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Carolina Urologic Research Center

    collaborator OTHER

  • Tulane University

    collaborator OTHER

  • Barbara Ann Karmanos Cancer Institute

    collaborator OTHER

  • MANA RBM

    lead OTHER

Principal Investigators

  • Neal Shore, MD · Carolina Urologic Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-03-07
Completion
2022-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237584 on ClinicalTrials.gov