Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System

Last updated: November 28, 2023
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Prostate Disorders

Treatment

Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D

Clinical Study ID

NCT05322356
2021-A01178-33
  • Ages > 18
  • Male

Study 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 determined by positive biopsies.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  • 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 theFrench public health code)

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
June 30, 2025

Study 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 implantation of 125 iodine implant with greater accuracy (using a 3D ultrasound image fusion registration system) in a target volume.

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.

Connect with a study center

  • Isabelle Boudry

    Grenoble, 38043
    France

    Active - Recruiting

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