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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04237584

Public ClinicalTrials.gov record NCT04237584. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 8:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide With Radium-223 vs Enzalutamide or Darolutamide With Placebo and the Effect Upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients

Study identification

NCT ID
NCT04237584
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
MANA RBM
Other
Enrollment
23 participants

Conditions and interventions

Interventions

  • Darolutamide during Lead-in Period Drug
  • Enzalutamide during Lead-in Period Drug
  • Lead-in Darolutamide followed by Placebo/Darolutamide Drug
  • Lead-in Darolutamide followed by Radium-223/Darolutamide Drug
  • Lead-in Enzalutamide followed by Placebo/Enzalutamide Drug
  • Lead-in Enzalutamide followed by Radium-223/Enzalutamide Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 29, 2020
Primary completion
Mar 6, 2022
Completion
Mar 6, 2022
Last update posted
Oct 6, 2022

2020 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Research Site Myrtle Beach South Carolina 29572

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04237584, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2022 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04237584 live on ClinicalTrials.gov.

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