Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol
Center Eugene Marquis
390 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria12
- 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
Exclusion Criteria9
- Presence of nodal or distant metastases
- Stage T4.
- Prostate volume \> 80 cm3.
- IPSS \>19/35.
- Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)
- Previous TransUrethral Resection of the prostate (PTUR)).
- Previous pelvic radiotherapy.
- Chronic inflammatory bowel disease.
- Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).
Interventions
The doses delivered will be: * the prostate gland, at a dose of 36.25 Gray, in 5 fractions, * the dominant intraprostatic lesion, up to 50 Gray, in 5 fractions, * seminal vesicles, at a dose of 25 Gray in 5 fractions, * pelvic lymph nodes, at 25 Gray in 5 fractions
* Conventional fractionation includes the prescription of a total dose of 78 Gray in 39 fractions to the prostate gland (and seminal vesicles, in case of T3b disease), and a dose de 50Gy in 25 fractions to pelvic nodal areas. * Moderate hypofractionation includes the prescription of a total dose of 60 Gray to the prostate gland (and seminal vesicles, in case of T3b disease), and 44 Gray to pelvic nodal areas in 20 fractions using a simultaneous integrated boost (SIB)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07189598