NCT07189598

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• High Risk Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)	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
PROCEDURE	conventional or a moderately hypofractionated	* 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)

Timeline

• Start date: 2026-04-01
• Primary completion: 2033-04-01
• Completion: 2033-04-01
• First posted: 2025-09-24
• Last updated: 2026-03-19

Locations

1 site across 1 country: France