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Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

NCT04136353 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.

Conditions

Interventions

RADIATION

External Beam Radiotherapy

All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.

DRUG

Darolutamide

2 x 300mg oral tablets twice daily for 96 weeks

DRUG

Placebo oral tablet

2 oral tablets twice daily for 96 weeks

DRUG

Luteinizing Hormone-Releasing Hormone Analog

All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.

Sponsors & Collaborators

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Cancer Trials Ireland

    collaborator NETWORK

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER

  • Prostate Cancer Clinical Trials Consortium

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Christopher Sweeney · Dana-Farber Cancer Institute and Harvard Medical School

  • Tamim Niazi · Jewish General Hospital and McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04136353 on ClinicalTrials.gov