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Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

NCT05116475 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-03-12

No results posted yet for this study

Summary

Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases

Conditions

Interventions

DRUG

Darolutamide 300 mg

Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

DRUG

Placebo of Darolutamide

Placebo of Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • Pierre COMBE, MD · Centre Oncologie Radiothérapie 37 - CORT37

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • France

Study Locations

More Related Trials

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 NCT05116475 on ClinicalTrials.gov