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Taking people in FranceNo phase

Tests adaptive radiotherapy with higher dose for high-risk prostate cancer

Compares adaptive body radiotherapy with standard radiotherapy in adults with high-risk prostate cancer.

Key facts

Who runs it
Center Eugene Marquis
Where
Rennes, FranceSee the site
Trial code
Registry title
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
Status
Recruiting
People taking part
390 people, planned
Started
2 Mar 2026
Expected to end
1 Apr 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
  • conventional or a moderately hypofractionated
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with high-risk prostate cancer that has not spread and has not been treated before. It tests adaptive stereotactic radiotherapy against standard radiotherapy.

Age
18 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma, high-risk or very high-risk (NCCN): T3a/T3b (proximal extension only), and/or ISUP grade 4-5, and/or PSA 20ng/mL. No spread to lymph nodes or other organs, shown by PSMA PET/CT and pelvic MRI less than 2 months before starting hormone therapy. ECOG performance status 0-2.
Earlier treatment
The prostate cancer must not have been treated before. Hormone therapy may be started, but testosterone must have been normal before it.
Biomarker or test result
Normal testosterone levels before hormone therapy.

Main reasons for not taking part

  • Cancer spread to lymph nodes or distant organs
  • Stage T4
  • Prostate volume above 80 cm3, or IPSS above 19/35
  • Earlier local prostate treatment (HIFU, cryotherapy), prostate resection (PTUR) or pelvic radiotherapy
  • Chronic inflammatory bowel disease, or recent heart attack or ischemic stroke (within the last 6 months)

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Presence of nodal or distant metastases
  • Stage T4
  • Prostate volume > 80 cm3
  • IPSS >19/35

Where in France

  • Centre Eugène MarquisRennes, FranceContact: Renaud Mr DE CREVOISIER, PRTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • innovative armTreatment being tested

    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

    Treatment: Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)

  • control armExisting treatment, for comparison

    Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week

    Treatment: conventional or a moderately hypofractionated

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol
Plain-language title
Tests adaptive radiotherapy with higher dose for high-risk prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 April 2026