Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol
The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).
• Male.
• Age ≥ 18 years
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• Histologically proven prostate adenocarcinoma, not previously treated
• High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :
‣ T3a / T3b (proximal extension only),
⁃ and/or ISUP (International Society of Urological Pathology) grade 4-5,
⁃ and/or PSA (Prostate-Specific Antigen) 20ng/mL
• Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy
• Normal testosterone levels prior to hormone therapy
• Ability to give consent for inclusion in the study
• Acceptance of treatment and monitoring modalities