APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

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.

Inclusion Criteria:Patients who have signed written informed consentAdult patients ≥ 18 yearsOligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions *, **All lesions must be amenable to SBRT in judgment of treating radiation oncologist ***Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administeredAndrogen deprivation therapy (ADT) started ≤ 6 months before enrollmentPatients should be eligible to Apalutamide treatmentExclusion Criteria:Presence of visceral diseaseDe novo metastatic diseaseAny contraindication to the use of ApalutamideAny condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated