ORION
Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol
Sponsor study identifier
interventional
390
1 country
1
Study Start
March 2, 2026
Actual (reported)Primary Completion
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2025
Actual (reported)September 24, 2025
Actual (reported)March 2, 2026
Actual (reported)April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
The primary endpoint is incremental cost effectiveness ratio (ICER) expressed as the cost for each healthy life-year gained at 5 years, with costs estimated from the National Health Data System (NHDS), overall survival (defined as the time between the 1st day of treatment and death from any cause), and utility estimated from clinical trial data
Five years after radiotherapy
Biochemical recurrence-free survival
Up to Year 5
Metastatic recurrence-free survival
Up to Year 5
Overall survival
Up to Year 5
Quality of life
Up to Year 5
Quality of life
Up to Year 5
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
Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week
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
Centre Eugène Marquis
Rennes, 35000, France
First Submitted
September 15, 2025
First Posted
September 24, 2025
Study Start
March 2, 2026
Actual (reported)Primary Completion
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
* 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)
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Study Completion
April 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 30, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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