Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Lymphatic Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

All Drugs and Chemicals

Androgens

Arm A: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Darolutamide ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

Arm B: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Placebo of Darolutamide

ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

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

Darolutamide 300 mg

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

Placebo of Darolutamide

Ishak Senouci

Pierre COMBE, MD

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

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.

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

The failure-free survival is defined as the time from the date of randomization to clinical (new cancer-related symptoms), biochemical (PSA rising) or radiological (local relapse or new metastases) progression, death, end of 3-year follow-up period or lost to follow-up, whichever occurs first.

To evaluate the metastasis-free survival rates

To evaluate the progression free survival rates

PSA response is defined by the rate of patients having a decrease of \> 50% of their PSA level, as measured every 3 months from the date of randomization to the date of a documented biochemical relapse.

Overall survival is defined as the time from the date of randomization to the date of documented death from any cause, end of 3-year follow-up period or lost to follow-up, whichever occurs first

Cancer-specific survival is defined as the time from the date of randomization to the date of documented death from prostate cancer or complication from the treatment, end of 3-year follow-up period or lost to follow-up, whichever occurs first

Time to pain progression is defined as the time from the date of randomization to the date of documented pain, end of 3-year follow-up period or lost to follow-up, whichever occurs first

To evaluate toxicities (CTCAE v5.0) due to treatements

Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORTC QLQ-C30 v2)

Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORC QLQ-PR25 V3)

Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORTC QLQ-PR253) by patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases	NCT05116475	Prostate Cancer	Darolutamide 30... Placebo of Daro...	18 Years - 120 Years	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases	NCT05116475	Prostate Cancer	Darolutamide 30... Placebo of Daro...	18 Years - 120 Years	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Spots Global Cancer Trial Database for placebo of darolutamide