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NCT Number: NCT07189598

Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer

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).

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Key information

Conditions

High Risk Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Eugène Marquis

Rennes, 35000, France

Location status: Recruiting

Location contact

Renaud Mr DE CREVOISIER, PR

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Procedure

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

conventional or a moderately hypofractionated

Procedure
  • 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)

Primary outcomes

  1. Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)

    Time frame: Five years after radiotherapy

    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

Secondary outcomes

  1. Biochemical recurrence-free survival

    Time frame: Up to Year 5

    defined as the time between date of randomization and date of biochemical recurrence, with biological recurrence defined according to Phoenix criteria.

  2. Metastatic recurrence-free survival

    Time frame: Up to Year 5

    Defined as the time from date of randomization to date of metastatic recurrence, metastatic recurrence being defined as the appearance of a lesion outside the target volume.

  3. Overall survival

    Time frame: Up to Year 5

    Defined as the time from date of randomization to date of death (from any cause)

  4. Quality of life

    Time frame: Up to Year 5

    defined with International Prostate Symptoms Score (IPSS)

  5. Quality of life

    Time frame: Up to Year 5

    Defined with Expanded Prostate Cancer Index Composite (EPIC) score

  6. Quality of life

    Time frame: Up to Year 5

    Defined with European Quality Of Life -5 Dimensions-5 Levels (EQ-5D-5L) scales

  7. Toxicity (GenitoUrea, GenitoIntestial, sexual) of the experimental arm

    Time frame: Up to Year 5

    graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer LE GUEVELOU, DR

CONTACT

[email protected]

0299253000 ext. +33

Renaud DE CREVOISIER, PR

CONTACT

[email protected]

0299253000 ext. +33

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study 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

Acronym: ORION

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Sep 24, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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