Table 2.

Study inclusion criteria

KEY INCLUSION CRITERIA

Age 18–80 years old ECOG PS 0–2 Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken by prostate biopsy Patients belonging to unfavorable intermediate group according to the D’Amico/NCCN risk group classification: Grade Group 3 or/and 2–3 risk factors for intermediate category (PSA 10–20/Grade Group 2–3/cT2a cT2b) or/and Biopsy cores positive ≥50% Patients belonging to a subclass of high-risk group according to the D’Amico/NCCN risk group classification: ISUP Group 4 (GS 4 + 4, 3 + 5, 5 + 3) or cT3a stage or PSA >20

Prostate protocol MRI for local staging Prostate volume less than 100 cc No pathologic lymph nodes and distant metastasis on PET scan or CT scan plus bone scan PSA detection maximum 60 days before randomization IPSS 0–15 Ability of the patient to understand and sign a written informed consent document Ability and willingness to comply with patients reported outcome questionnaires schedule during the study time Contraceptive measures for patients with partners with reproductive potential must be explained

ECOG, Eastern Cooperative Oncology Group; PET, positron emission tomography; PSA, prostate-specific antigen.