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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.
Placebo of Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, France
RECRUITINGFailure-free survival FFS
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.
Time frame: 3 years
Metastasis-free survival rates
To evaluate the metastasis-free survival rates
Time frame: 3 years
Progression free survival rate
To evaluate the progression free survival rates
Time frame: 3 years
PSA response levels
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.
Time frame: 3 years
Overall survival rates
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
Time frame: 3 years
Cancer-specific survival rates
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 frame: 3 years
Time to pain progression
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 years
Toxicities
To evaluate toxicities (CTCAE v5.0) due to treatements
Time frame: 3 years
Quality of life of the patient
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)
Time frame: 3 years
Quality of life of the patient
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)
Time frame: 3 years
Quality of life of the participants
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
Time frame: 3 years