Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Trial Parameters
Brief Summary
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate 2. ECOG performance status 0-1 3. Ability to swallow oral medications and comply with study procedures and requirements. 4. Males ≥18 years 5. Participants must have adequate organ and marrow function as below: 1. Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L; 2. Platelets ≥100,000/mm3 or ≥100 x 109/L; 3. Hemoglobin ≥8 g/dL (may have been transfused). 4. Estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation. 5. Total serum bilirubin \<1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome; 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN. 6. Must be a candidate for RP 7. Clinical stage cT2-4, N0-1 8. Mandatory to identify tumor availability (≥10 FFPE slides, 5 µM thickness \& 1 stained H\&E slide OR tumor block) 9. High-risk PCa defined as one of the followin