RecruitingRecruiting
Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer
NCT07344844 · Clinique Sainte Clotilde
In plain English
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Official title
Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
About this study
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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-18
Estimated completion: 2029-05-01
Last updated: 2026-01-15
Interventions
Other: Low-dose CT imaging before each SBRT session
Primary outcomes
- • Proportion of patients requiring dosimetric recalculation due to anatomical variations (At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.)
Sponsor
Clinique Sainte Clotilde · other
Contacts & investigators
ContactMANON Leprince, Clinical Research Associate · contact · manon.leprince@clinifutur.net · 0692341365
ContactMickael Begue, Principal Investigator · contact · manon.leprince@clinifutur.net
InvestigatorYoussef Slama · study_chair, Clinique Sainte Clotilde
All locations (1)
Clinique Sainte ClotildeRecruiting
Saint-Denis, Reunion