Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-… (NCT07189598) | Clinical Trial Compass
RecruitingNot Applicable
Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
France390 participantsStarted 2026-03-02
Plain-language 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).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)