APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer (PERSIAN)

APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN

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.

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.

Patients will be randomized between control arm (Androgen Deprivation therapy and Apalutamide) or treatment arm (Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease)

oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

Measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.

Inclusion Criteria: Patients who have signed written informed consent Adult patients ≥ 18 years Oligometastatic 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 administered Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment Patients should be eligible to Apalutamide treatment Exclusion Criteria: Presence of visceral disease De novo metastatic disease Any contraindication to the use of Apalutamide Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

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