Recruiting NCT07189598
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: High Risk Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- 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)
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Biochemical recurrence-free survival [Time frame: Up to Year 5]
- Metastatic recurrence-free survival [Time frame: Up to Year 5]
- Overall survival [Time frame: Up to Year 5]
- Quality of life [Time frame: Up to Year 5]
- Quality of life [Time frame: Up to Year 5]
- Quality of life [Time frame: Up to Year 5]
- Toxicity (GenitoUrea, GenitoIntestial, sexual) of the experimental arm [Time frame: Up to Year 5]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Eugène Marquis — Rennes
Identifiers
NCT: NCT07189598 · 2024-2-75-001