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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated by SBRT with pre-session low-dose CT | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose CT imaging before each SBRT session | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring dosimetric recalculation due to anatomical variations | 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. | At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative delivered dose to Organs at Risk (OARs) | Definition: Quantitative assessment of the dose actually delivered to each OAR across all fractions, based on dose-volume parameters derived from the low-dose CTs and DVH (Dose-Volume Histogram) analyses. OARs and parameters include: Rectum Maximum dose (0.03 cc) Dose to 3 cc Dose to 10%, 20%, and 50% of the volume Bladder Maximum dose (0.03 cc) Dose to 10% and 50% of the volume Penile bulb Maximum dose Dose to 3 cc Femoral heads Dose to 10 cc (combined left and right) Maximum dose Bowel (GETUG-14 constraints) D5cc D1cc Urethra Maximum dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MANON Leprince, Clinical Research Associate | Contact | 0692341365 | manon.leprince@clinifutur.net | |
| Mickael Begue, Principal Investigator | Contact | manon.leprince@clinifutur.net |
| Name | Affiliation | Role |
|---|---|---|
| Youssef Slama | Clinique Sainte Clotilde | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Sainte Clotilde | Recruiting | Saint-Denis | 97404 | Reunion |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| From baseline CT + all 5 fraction low-dose CT scans. (up to 10 days) |
| Change from baseline in global quality of life (EORTC QLQ-C30) | Change from baseline in global quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Score range: 0-100 Higher scores indicate better quality of life. | Time Frame: Baseline (pre-radiotherapy) 1 month 3 months 6 months 12 months 18 months 24 months post-radiotherapy |
| Survival outcomes | Overall Survival (OS): Death from any cause. | 1, 3, 6, 12, 18, 24 months post-radiotherapy |
| Recurrence-Free Survival (RFS) | Clinical, biochemical, or radiological recurrence. | 1, 3, 6, 12, 18, 24 months post-radiotherapy |
| Change from baseline in prostate cancer-specific quality of life (EORTC QLQ-PR25) | Change from baseline in prostate cancer-specific quality of life domains assessed using the EORTC QLQ-PR25 questionnaire. Score range: 0-100 Higher scores indicate worse symptoms. | Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy |
| Change from baseline in urinary symptoms (IPSS) | Change from baseline in urinary symptoms assessed using the International Prostate Symptom Score (IPSS). Score range: 0-35 Higher scores indicate worse urinary symptoms. | Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |