Phase III Radium 223 mCRPC-PEACE III

NCT02194842 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2025-09-19

No results posted yet for this study

Summary

The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) by investigator assessment compared to enzalutamide single agent in castration resistant prostate cancer (CRPC) patients metastatic to bone

Conditions

Interventions

DRUG

Ra223

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY
  • Astellas Pharma Europe Ltd.

    collaborator INDUSTRY
  • UNICANCER

    collaborator OTHER
  • Canadian Urologic Oncology Group

    collaborator OTHER
  • Latin American Cooperative Oncology Group

    collaborator OTHER
  • Cancer Trials Ireland

    collaborator NETWORK
  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Bertrand Tombal, Prof · Cliniques Universitaires de Saint Luc

  • Silke Gillessen, Prof · Oncology Institute of Southern Switzerland - Ospedale San Giovanni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2024-02-19
Completion
2028-12-31

Countries

  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Ireland
  • Italy
  • Norway
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT02194842 on ClinicalTrials.gov