Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
NCT ID: NCT05322356
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-04-04
2025-06-30
Brief Summary
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Detailed Description
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For this purpose, positive biopsies, performed in this research protocol, will be used prior to surgery. Prostate brachytherapy will be optimised thanks to the TRINITY® system and its guidance quality, by increasing the dose of the intra-prostate tumour volume (BOOST) without increasing the total dose delivered to the prostate. Increasing the dose to the tumour target volume could improve disease control and decrease the risk of recurrence.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the 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
Target dose supplement with the TRINITY® PERINE 3D system
Interventions
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Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
Target dose supplement with the TRINITY® PERINE 3D system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
Koelis
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Carole Iriard, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Isabelle Boudry
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Centre d'Investigation Clinique Innovation Technologique
Other Identifiers
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2021-A01178-33
Identifier Type: -
Identifier Source: org_study_id