Adaptive stereotactic body radiotherapy with pelvic treatment and focal dose boost 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
This trial will try an adaptive form of focused high-dose radiation to the prostate and pelvic lymph nodes, with an extra dose to the main tumor area, for men with high-risk prostate cancer to see if it improves outcomes and cost-effectiveness compared with standard radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Center Eugene Marquis Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT07189598 on ClinicalTrials.gov |
What this trial studies
This phase III randomized trial compares an adaptive stereotactic body radiotherapy (SBRT) approach that combines whole pelvic radiotherapy (WPRT) with dose escalation to the dominant intraprostatic lesion (DIL) against standard conventional or moderately hypofractionated radiotherapy. Eligible men have newly diagnosed, non-metastatic high or very high-risk prostate adenocarcinoma confirmed by PSMA PET/CT and pelvic MRI, and will receive protocol-defined imaging and hormone therapy as appropriate. The study will measure oncologic outcomes, safety, urinary and sexual function, and includes a 5-year cost-utility analysis using trial data plus the National Health Data System (NHDS). Treatments and follow-up imaging are delivered at Centre Eugène Marquis with scheduled visits to monitor efficacy and side effects.
Who should consider this trial
Good fit: Adult men (≥18) with newly diagnosed, non-metastatic high or very high-risk prostate adenocarcinoma, ECOG 0–2, normal pre-treatment testosterone, able to undergo PSMA PET/CT and pelvic MRI, and willing to attend centre-based treatment and follow-up.
Not a fit: Patients with nodal or distant metastases, stage T4 disease, prostate volume >80 cm3, severe urinary symptoms (IPSS >19), or prior local prostate treatment are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve cancer control while shortening treatment time and may be more cost-effective than standard radiotherapy.
How similar studies have performed: Smaller trials and observational studies have shown promising results for SBRT and focal DIL boosting, but randomized phase III evidence specifically combining whole pelvic RT with adaptive DIL dose escalation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Rennes
- Centre Eugène Marquis — Rennes, France (Recruiting)
Study contacts
- Study coordinator: Jennifer LE GUEVELOU, DR
- Email: jennifer.leguevelou@gmail.com
- Phone: 0299253000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.