A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Participants must be 18 years or older at the time of signing the informed consent.
Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).
No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.
Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
Participants must have at least one of the following features according to NCCN definition of high-risk:
* Biopsy Gleason score ≥8, and/or
* Prostate-specific antigen (PSA) \>20 ng/mL measured during Screening and prior to randomization, or
* Clinical stage ≥ T3a.
Participants with pelvic lymph node involvement (N1) can be included.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
You may not be if
Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous \[IV\] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
History of
* Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
* Significant cardiovascular disease within 6 months prior to randomization.
* Any contraindications for RP.
Uncontrolled or treatment-resistant hypertension.
History of another malignancy within 5 years prior to randomization.
Clareo Health | A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
