Radiotherapy Targeting Limited Progression in Men With Castration Resistant Metastatic Prostate Cancer to Delay Next Treatment

What this Trial Is About

Researchers are evaluating the addition of metastasis-directed radiotherapy MDRT to the standard care for patients with metastatic castration-resistant prostate cancer mCRPC who show oligoprogression, defined as progression in up to three lesions seen on PSMA PET scans. This condition arises when prostate cancer becomes resistant to hormone therapy, leading to limited treatment options and a median survival of 2-3 years. The study aims to determine if MDRT can delay the need for next line systemic therapy NEST and improve radiological progression-free survival rPFS. This is a single-arm, multicenter phase II trial involving 35 patients. Participants will receive MDRT targeting up to three progressive metastatic or local lesions, preferably using stereotactic body radiotherapy SBRT. Patients included have an indication to start NEST and are currently treated with androgen deprivation therapy ADT, alone or combined with chemotherapy or androgen receptor-targeted agents ARTA. The study focuses on well-selected patients with oligoprogressive disease to test whether adding MDRT postpones further systemic treatment. During the study, patients will be monitored for radiological progression using PSMA PET imaging and assessed for quality of life, biochemical progression, overall survival, and treatment-related toxicities up to 36 months. Primary outcomes include NEST-free survival and radiological progression-free survival measured at 6, 12, and 24 months. Safety assessments will track gastrointestinal and genitourinary toxicities for up to two years after radiotherapy. This comprehensive follow-up aims to evaluate the potential benefits and risks of MDRT in this patient group.

The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)