OncoMatch/Clinical Trials/NCT05116475
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
Is NCT05116475 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Darolutamide 300 mg for prostate cancer.
Treatment: Darolutamide 300 mg — Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage ANY T
Metastatic disease required
Any T stage; N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy for locally-advanced prostate cancer
Exception: LH-RH agonist or antagonist up to 3 months before randomization
Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
Cannot have received: second generation androgen receptor inhibitor (enzalutamide, apalutamide, darolutamide)
Second generation AR inhibitors such as enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201) other investigational AR inhibitors
Cannot have received: CYP17 enzyme inhibitor (abiraterone acetate, TAK-700)
CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700
Cannot have received: oral ketoconazole (ketoconazole)
Oral ketoconazole
Cannot have received: estrogen
Use of estrogens
Cannot have received: androgen receptor inhibitor (bicalutamide, flutamide, nilutamide, cyproterone acetate)
AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate)
Lab requirements
Blood counts
hemoglobin ≥ 9.0 g/dl, absolute neutrophil count ≥ 1500/μl, platelet count ≥ 100,000/μl (patient must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening)
Kidney function
creatinine < 2.0 x ULN
Liver function
ALT and/or AST < 2.5 x ULN, total bilirubin < 1.5 x ULN (except patients with a diagnosis of Gilbert's disease)
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). 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05116475 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for locally-advanced prostate cancer, second generation androgen receptor inhibitor, CYP17 enzyme inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage ANY T is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 120 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages