Actively Recruiting
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
Led by Center Eugene Marquis · Updated on 2026-04-30
390
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Age 18 years or older
- ECOG performance status 0-2
- Histologically confirmed prostate adenocarcinoma, not previously treated
- High-risk or very high-risk prostate cancer defined by T3a/T3b (proximal extension), and/or ISUP grade 4-5, and/or PSA 20 ng/mL
- Non-metastatic confirmed by PSMA PET/CT and pelvic MRI within 2 months before hormone therapy
- Normal testosterone levels before hormone therapy
- Ability to provide informed consent
- Acceptance of treatment and monitoring procedures
You will not qualify if you...
- Presence of nodal or distant metastases
- Stage T4 prostate cancer
- Prostate volume greater than 80 cm3
- IPSS score greater than 19/35
- Previous local prostate adenocarcinoma treatment (HIFU, cryotherapy)
- Previous TransUrethral Resection of the prostate (PTUR)
- Previous pelvic radiotherapy
- Chronic inflammatory bowel disease
- Active cardiovascular conditions such as myocardial infarction or ischemic stroke within past 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Eugène Marquis
Rennes, France, 35000
Actively Recruiting
Research Team
J
Jennifer LE GUEVELOU, DR
CONTACT
R
Renaud DE CREVOISIER, PR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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