Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer
Recruiting · NCT07344844 · Interventional (participants receive a specific treatment) · Lead sponsor: Clinique Sainte Clotilde
View the official record on ClinicalTrials.gov →Interventions studied
Low-dose CT imaging before each SBRT session
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Clinique Sainte Clotilde - Saint-Denis, Reunion