Informations générales (source: ClinicalTrials.gov)

NCT05322356 En recrutement
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
  • Tumeurs de la prostate
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.
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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 En recrutement 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



- 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)