Safety and Feasibility of Darolutamide and Relugolix Before Radical Prostatectomy for High-Risk Prostate Cancer in Adult Men A Phase 1 Trial of Combination Neoadjuvant Therapy

What this Trial Is About

Researchers are evaluating the safety and feasibility of a new combination of darolutamide and relugolix as a pre-surgery treatment for adult males with high-risk prostate cancer. This phase 1 trial focuses on men who are candidates for radical prostatectomy to treat localized or locally advanced prostate cancer. The study aims to understand how well patients tolerate this combination before surgery and monitor for any treatment-related side effects. Participants will receive darolutamide orally at a dose of 600 mg twice daily and relugolix with a loading dose of 360 mg on the first day followed by 120 mg once daily. After completing this neoadjuvant therapy, radical prostatectomy will be performed between 48 hours and 2 weeks later. This treatment arm is designed to assess the combinations safety and feasibility prior to surgery. During the study, patients will be monitored for adverse events up to 8 weeks after surgery, and researchers will measure objective radiographic response, prostate-specific antigen PSA levels, and blood concentrations of the drugs during treatment cycles. The total participation includes treatment, surgery, and follow-up assessments to evaluate safety and therapy completion rates.

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer