AdventHealth
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.
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…
600 mg (two 300 mg tablets) taken orally twice daily.
A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.
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