Clinical trial · Interventional
Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D Ultrasound System
NCT05322356CI-TRIAL-00110088FOCUS-BOOSTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D system
- interventionNames
- Other: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
Primary outcomes (1)
- measure
- Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.
- timeFrame
- 24 hours
- description
- To evaluate the number of successful/failed iodine 125 implants (BOOST implants) implanted in the CTV-boost (Clinical Target Volume) defined from the mapping of positive biopsies. The maximum number of BOOST implant implanted will be 4 implants, depending on the size of the target: 10 mm\< target ≤ 15 mm = 2 implants; 15 mm \< target ≤ 20mm = 3 implants; 20 mm \< target ≤ 30 mm = 4 implants; Success is defined as "the centre of the implant is in the target volume". Failure is defined as "the centre of the implant is outside the target volume". The primary endpoint is evaluated on the ultrasound acquisition performed with the Trinity® Perine probe, at the end of the BOOST implant insertion procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years * Patient to be treated with brachytherapy * Patient with low or favorable intermediate risk prostate adenocarcinoma ISUP 1 and 2, G6 (3+3) or G7 (3+4) * Life expectancy of more than 10 years * PSA (prostate-specific antigen) \< 15 ng/ml * cT1c or cT2a or cT2b * Prostate volume ≤ 60 cc * ECOG Performance status 0-2 * Patient is affiliated to a health insurance system * Patient who has signed consent form Exclusion Criteria: * Patient with urinary function disorders IPSS\> 14 * Prostate volume \> 60cc. * Gleason 7(4+3) or Gleason score ≥8 * PSA ≥ 15 ng/ml * Patient with metastases * Hormone therapy with antiandrogen or LHRH analogue * History of abdominopelvic irradiation * Inflammatory digestive disease (haemorrhagic rectocolitis, Crohn's disease) * Interventional study in progress that may interfere with the present study * Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)
References
Publications (0)
Data not yet available
No reference posted for this study.