NCT07344844 Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer
| NCT ID | NCT07344844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinique Sainte Clotilde |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 100 participants in total. It began in 2025-11-18 with a primary completion date of 2029-03-01.
⚠ 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
This study evaluates whether adaptive stereotactic body radiotherapy (SBRT) provides dosimetric advantages compared to non-adaptive SBRT in localized prostate cancer. Five low-dose CT scans are performed before each SBRT session to assess anatomical variations (bladder filling, rectal volume) and determine if a dosimetric recalculation would have been required. The study also evaluates cumulative dose to organs at risk, patient-reported quality of life over 24 months, and overall and recurrence-free survival.
Eligibility 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
Contact & Investigator
Youssef Slama
STUDY CHAIR
Clinique Sainte Clotilde
Frequently Asked Questions
Who can join the NCT07344844 clinical trial?
This trial is open to male participants only, aged 60 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07344844 currently recruiting?
Yes, NCT07344844 is actively recruiting participants. Contact the research team at manon.leprince@clinifutur.net for enrollment information.
Where is the NCT07344844 trial being conducted?
This trial is being conducted at Saint-Denis, Reunion.
Who is sponsoring the NCT07344844 clinical trial?
NCT07344844 is sponsored by Clinique Sainte Clotilde. The principal investigator is Youssef Slama at Clinique Sainte Clotilde. The trial plans to enroll 100 participants.
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