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Recruiting NCT07344844

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

Trial Parameters

Condition Prostate Cancer (Adenocarcinoma)
Sponsor Clinique Sainte Clotilde
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex MALE
Min Age 60 Years
Max Age N/A
Start Date 2025-11-18
Completion 2029-03-01
Interventions
Low-dose CT imaging before each SBRT session

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

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