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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05116475•Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 120 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. . Newly diagnosed, histologically confirmed prostate adenocarcinoma
•2. ≥ 18 years old.
•3. Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
•4. Any T stage
•5. N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace).
•6. Intention to treat with long-term androgen deprivation therapy (24 months).
•7. Hormonal therapy with LH-RH agonist or antagonist is allowed up to 3months prior to randomization.
•8. Able to receive protocol therapy and have life expectancy of at least 36 months, ECOG Performance Status (PS) 0-2.
•9. . Blood counts at screening: hemoglobin ≥ 9.0 g/dl, absolute neutrophil count ≥ 1500/μl (1.5x109/l), platelet count ≥ 100,000/μl (100x109/l ) (patient must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).
•10. Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) \< 2.5 x upper limit of normal (ULN), total bilirubin \< 1.5 x ULN (except patients with a diagnosis of Gilbert's disease), creatinine \< 2.0 x ULN.
+5 more criteria

Exclusion Criteria

•1. Lymph nodes metastases outside of the pelvis
•2. Bone or visceral metastases
•3. Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
•4. Prior treatment with:
•* Second generation AR inhibitors such as enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201) other investigational AR inhibitors
•* CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
•* Oral ketoconazole
•* Use of estrogens, or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate)
•5. Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomization.
•6. Patients with QTor QTc interval \> 450 ms on the ECG
+15 more criteria

Locations (1)

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, France

Key Dates

Start Date

August 30, 2022

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2027

Last Updated

March 12, 2024

Enrollment

152

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Darolutamide 300 mg

DRUG

Placebo of Darolutamide

DRUG

Contacts

Ishak Senouci

CONTACT

0766185461 ishak.senouci@association-artic.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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