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Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

RECRUITINGN/ASponsored by Clinique Sainte Clotilde
Actively Recruiting
PhaseN/A
SponsorClinique Sainte Clotilde
Started2025-11-18
Est. completion2029-03-01
Eligibility
Age60 Years+
SexMALE
Healthy vol.Accepted

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

Age: 60 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer (Adenocarcinoma)

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