START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Trial Parameters
Brief Summary
Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. Patients with a histological diagnosis of prostate cancer. 2. Castration sensitive prostate cancer patients. 3. Oligometastatic disease defined as less than or equal 3 lesions based on CT and Bone Scan and less than or equal 5 lesions based on Choline or PSMA PET/TC. Bone metastases (including the spine) or/and lymph nodes metastases. 4. Informed consent is obtained from the patient. 5. Adequate bone-marrow, liver and renal function: * Haemoglobin ≥10 g/dL, Leucocytes ≥ 2000/mm\^3, Neutrophils ≥1500/mm\^3, platelets ≥1000007mm\^3 * GOT, GPT and Total Bilirrubin ≤1.5\*ULN (Upper limit of normality) * Creatinine ≤1.5\*ULN or Creatinine Clearance ≥50 ml/min\^-1 Exclusion Criteria: 1. Lack of a histological diagnosis of prostate cancer. 2. Castration resistant prostate cancer patients according to PCWG3\[30\]. 3. Metastatic disease defined as greater than or equal 3 lesions based on CT and Bone Scan and greater than or equal 5 lesions based on Choline or PSMA PET/TC.