A Phase 2 interventional study of Focal brachytherapy in Localized Prostate Cancer, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Institut Claudius Regaud · Phase 2, Interventional, and Treatment
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).
The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 18 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
Exclusion Criteria:
Focal brachytherapy with permanent I125 localized implant.
Radiation: Focal brachytherapy
Focal brachytherapy with permanent I125 localized implant.
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
Time frame: 3 years
Progression-free-survival according to Phoenix criterion
Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion
Time frame: 3 years
Quality of life study using 3 Patient questionnaires
Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire
Time frame: 3 years
Absence of tumor residuals in the target treated zone
The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation
Time frame: 3 years
Toxicity evaluation
Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Time frame: 3 years
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Institut Claudius Regaud