Status:
UNKNOWN
Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Clinical Investigation Centre for Innovative Technology Network
Koelis
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 determ...
Detailed Description
The interstitial brachytherapy procedure for the prostate does not allow for a robust focal treatment to accurately deliver additional dose to the tumour volume. FOCUS BOOST allows the precise implant...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05322356
Start Date
April 4 2023
End Date
June 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
Isabelle Boudry
Grenoble, France, 38043