Clinical trial · Interventional
Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer
Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose CT imaging before each SBRT session | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients treated by SBRT with pre-session low-dose CT
- description
- 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.
- interventionNames
- Other: Low-dose CT imaging before each SBRT session
Primary outcomes (1)
- measure
- Proportion of patients requiring dosimetric recalculation due to anatomical variations
- timeFrame
- At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.
- description
- Percentage of patients for whom at least one stereotactic body radiotherapy (SBRT) fraction would have required a dosimetric recalculation due to anatomical variations (bladder filling and/or rectal emptying), based on comparison between the initial treatment plan and pre-treatment low-dose CT scans acquired before each SBRT fraction (5). This outcome reflects the potential benefit of an adaptive radiotherapy approach compared to a non-adaptive strategy.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
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 formReferences
Publications (0)
Data not yet available