NCT05322356Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 24 Nov 2021
- Start date
- Apr 2023
- Primary completion date
- Jul 2025
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Prostate cancer
- NCT number
- NCT05322356
What you commit to
- Study type: Interventional
- Planned participants: 15
- From Apr 2023 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hormone therapy with antiandrogen or LHRH analogue
Other illness
- Patient with urinary function disorders IPSS\> 14
- History of abdominopelvic irradiation
- Inflammatory digestive disease (haemorrhagic rectocolitis, Crohn's disease)
Other
- Prostate volume \> 60cc.
- Gleason 7(4+3) or Gleason score ≥8
- PSA ≥ 15 ng/ml
- Patient with metastases
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Isabelle Boudry Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.