Informations générales (source: ClinicalTrials.gov)
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 (FOCUS-BOOST)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
avril 2023
juin 2025
29 juin 2024
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.
Etablissements
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
Isabelle Boudry - 38043 - Grenoble - France | Isabelle Boudry, PhD | Contact (sur clinicalTrials) |
Critères
Homme
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
- 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
- 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)