Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.