An interventional study of Low-dose CT imaging before each SBRT session in Prostate Cancer (Adenocarcinoma), sponsored by Clinique Sainte Clotilde. Recruiting at 1 site in Reunion. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Clinique Sainte Clotilde · Not applicable, Interventional, and Diagnostic
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Clinique Sainte Clotilde is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Low-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.
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.
Time frame: At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.
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
Time frame: 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: 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.
Time frame: 1, 3, 6, 12, 18, 24 months post-radiotherapy
Recurrence-Free Survival (RFS)
Clinical, biochemical, or radiological recurrence.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Mar 2029, 39 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 39 months is close to that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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Clinique Sainte Clotilde