RecruitingPhase 3NCT05116475

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


Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Enrollment

152 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial (EDAD) is testing whether adding darolutamide — an oral anti-androgen drug — to the standard treatment of hormone therapy plus radiation improves outcomes in men with newly diagnosed prostate cancer that has spread to pelvic lymph nodes. Standard treatment already includes hormone therapy and radiation; this trial asks whether a third drug makes a meaningful difference. **You may be eligible if...** - You are 18 or older with a new diagnosis of prostate cancer that has spread to pelvic lymph nodes (N1 stage) - Your cancer has been confirmed by biopsy - You are planned for long-term hormone therapy (24 months) plus radiation - You are in good enough health to tolerate the treatment (ECOG 0–2, at least 3 years life expectancy) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread beyond the pelvis - You have already received chemotherapy or radiation for prostate cancer - You have significant heart, liver, or other organ problems that make treatment unsafe - You are unable to comply with contraception requirements if applicable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarolutamide 300 mg

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

DRUGPlacebo of Darolutamide

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


Locations(1)

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, France

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NCT05116475


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