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Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

NCT04736199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2026-02-27

Study results available
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Summary

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Darolutamide (Nubeqa, BAY1841788)

Coated tablet, oral administration

DRUG

Placebo

Coated tablet matching Darolutamide in appearance, oral administration

OTHER

Androgen deprivation therapy (ADT)

Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2024-06-07
Completion
2026-01-23
FDA Drug
Yes

Countries

  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • India
  • Latvia
  • Lithuania
  • New Zealand
  • Peru
  • Russia
  • South Africa
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT04736199 on ClinicalTrials.gov