NCT05116475

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Standard of care for patients with prostate cancer (PC) with pelvic lymph nodes metastases is radiotherapy (RT) with long-term androgen deprivation therapy (ADT). . Darolutamide improves survival in men with castration-refractory non metastatic prostate cancer. We hypothesize that adding Darolutamide to ADT and RT could improve FFS for these high-risk patients.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2021-11-11
• Last updated: 2024-03-12

Locations

1 site across 1 country: France