RecruitingNot ApplicableNCT07189598

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


Sponsor

Center Eugene Marquis

Enrollment

390 participants

Start Date

Mar 2, 2026

Study Type

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of highly focused radiation treatment called SBRT (stereotactic body radiotherapy) for men with high-risk prostate cancer. Researchers want to see if adapting and potentially increasing the radiation dose improves cancer control. **You may be eligible if...** - You are male and 18 or older - You have been newly diagnosed with high-risk or very high-risk prostate cancer (based on tumor stage, Gleason/ISUP grade, or PSA level) - Your cancer has not spread to lymph nodes or other organs (confirmed by PSMA PET scan and MRI) - You have not had any prior prostate cancer treatment - You are well enough to participate (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant sites - Your prostate is very large (greater than 80 cm³) - You have significant urinary symptoms (high IPSS score above 19) - You have had prior prostate procedures such as HIFU, cryotherapy, or a TURP - You have had prior pelvic radiation - You have chronic inflammatory bowel disease or recent serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAdaptive 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

PROCEDUREconventional 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)


Locations(1)

Centre Eugène Marquis

Rennes, France

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NCT07189598


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