NCT07189598 Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer
| NCT ID | NCT07189598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Center Eugene Marquis |
| Condition | High Risk Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2033-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 390 participants in total. It began in 2026-03-02 with a primary completion date of 2033-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07189598 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying High Risk Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07189598 currently recruiting?
Yes, NCT07189598 is actively recruiting participants. Contact the research team at jennifer.leguevelou@gmail.com for enrollment information.
Where is the NCT07189598 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT07189598 clinical trial?
NCT07189598 is sponsored by Center Eugene Marquis. The trial plans to enroll 390 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.