Adaptive targeted stereotactic radiotherapy for localized prostate cancer
Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
This tests whether doing a quick low-dose CT scan before each SBRT session to adapt the treatment plan reduces radiation to the bladder and rectum and preserves quality of life for men aged 60 and older with low- or intermediate-risk localized prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | Male |
| Sponsor | Clinique Sainte Clotilde Academic / other |
| Locations | 1 site (Saint-Denis) |
| Trial ID | NCT07344844 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study acquires low-dose CT images before each SBRT session to document anatomical variations such as bladder filling and rectal volume. Investigators determine whether a dosimetric recalculation would have been required and compare cumulative dose to organs at risk between adaptive and non-adaptive approaches. Patient-reported quality of life is collected over 24 months and clinical endpoints include overall and recurrence-free survival. Participants are treated at Clinique Sainte Clotilde in Saint-Denis and must be French-speaking and covered by the French social security system.
Who should consider this trial
Good fit: Men aged 60 or older with localized low- or intermediate-risk (T1-T2, Gleason 6–7) prostate adenocarcinoma, PSA <15 ng/mL, suitable for radiotherapy, French-speaking, and covered by the French social security system are ideal candidates.
Not a fit: Patients with high-risk or metastatic disease, prior prostate or relevant digestive surgery that alters anatomy, those unable to personally provide informed consent, or those who do not speak or read French are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adaptive SBRT could lower radiation exposure to the bladder and rectum, reduce treatment side effects, and help preserve quality of life while maintaining cancer control.
How similar studies have performed: Previous image-guided and adaptive radiotherapy work for prostate cancer has shown dosimetric improvements and reduced organ-at-risk exposure, but long-term clinical benefits are not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Male aged ≥60 years
* Localized prostate cancer of low or intermediate risk (T1-T2)
* Gleason score 6-7
* PSA \<15 ng/mL
* No evidence of metastatic disease
* Radiotherapy indicated for prostate cancer
* Affiliated with or benefiting from a French social security system
* French-speaking patient
* Patient appropriately informed and having signed a written informed consent form
Exclusion Criteria:
* Unable to read, write, or understand French
* Vulnerable patient as defined by Article L1121-6 of the French Public Health Code
* Adult under guardianship, curatorship, or legal protection ("sauvegarde de justice")
* Patient unable to personally provide informed consent according to Article L1121-8 of the French Public Health Code
* Patient already included in another interventional study that could interfere with study outcomes
* History of urological (prostate) or digestive surgery that could influence study outcomes
* Refusal to sign the written informed consent form
Where this trial is running
Saint-Denis
- Clinique Sainte Clotilde — Saint-Denis, Reunion (Recruiting)
Study contacts
- Study coordinator: MANON Leprince, Clinical Research Associate
- Email: manon.leprince@clinifutur.net
- Phone: 0692341365
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.