Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL) | Procedure | — | UNRESOLVED |
| conventional or a moderately hypofractionated | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- innovative arm
- description
- Participants treated with Stereostatic Body RadioTherapy (SBRT) will be administered an adaptative stereostactic, ultra-fractionated radiotherapy every other day, for a total treatment time of 10 days. Total treatment time should not exceed 17 days
- interventionNames
- Procedure: Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week
- interventionNames
- Procedure: conventional or a moderately hypofractionated
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
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