Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.
To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT). In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement. For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.
• Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken
• Prostate protocol MRI for local staging
• Patients belonging to intermediate unfavorable 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 ng/ml/ Grade group 2-3/ cT2b cT2c) 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
• Eastern Coooperative Oncology Group (ECOG) PS 0-2
• 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
• IPSS 0-15
• Prostate Volume less than 100cc
• PSA must be dosed maximum 60 days before randomization
• No pathologic lymph nodes and distant metastasis on PET (fluorocholine) scan or CT scan+bone scan.
• Contraceptive measures for patients with partners with reproductive potential must be explained