RecruitingNot ApplicableNCT07344844

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique


Sponsor

Clinique Sainte Clotilde

Enrollment

100 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 60 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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

Interventions

OTHERLow-dose CT imaging before each SBRT session

Five low-dose, non-contrast CT scans performed immediately before each SBRT session (≈10 min before treatment) to assess anatomical variations impacting target volume and organ-at-risk dosimetry.


Locations(1)

Clinique Sainte Clotilde

Saint-Denis, Reunion

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NCT07344844


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