Prospective trial evaluates biochemical response in prostate cancer with concurrent ultrahypofractionated radiotherapy and relugolix, suggesting improved outcomes.
Key Points
The study aims to evaluate the effectiveness of combining short-course oral relugolix with ultrahypofractionated radiotherapy in intermediate-risk prostate cancer patients.
Prospective, single-arm Phase II trial design.
Participants: patients with unfavorable intermediate risk prostate carcinoma.
Treatment: 36.25 Gy in 5 fractions of ultrahypofractionated radiotherapy accompanied by short-course oral relugolix.
Oral relugolix dosed at 360 mg for an attack dose, followed by 120 mg daily for 6 months.
Primary endpoint: rate of complete biochemical response measured at 6 months post-treatment.
Enrollment of 20 patients initiated in May 2025, with a goal of 73 patients.
Expected proportion of patients with complete biochemical response aimed at <0.5 ng/ml at 6 months.
Intervention anticipated to yield improved testosterone recovery compared to historical treatments.