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

NCT05322356 | Active Not Recruiting

• 1 other identifier: 2021-A01178-33
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 determined by positive biopsies.

Conditions

Prostate Cancer

Keywords

Interstitial brachytherapy; Iodine 125 implant; 3D TRINITY® Perine system

Outcome Measures

Primary Outcomes (1)

• Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.

  To evaluate the number of successful/failed iodine 125 implants (BOOST implants) implanted in the CTV-boost (Clinical Target Volume) defined from the mapping of positive biopsies. The maximum number of BOOST implant implanted will be 4 implants, depending on the size of the target: 10 mm\< target ≤ 15 mm = 2 implants; 15 mm \< target ≤ 20mm = 3 implants; 20 mm \< target ≤ 30 mm = 4 implants; Success is defined as "the centre of the implant is in the target volume". Failure is defined as "the centre of the implant is outside the target volume". The primary endpoint is evaluated on the ultrasound acquisition performed with the Trinity® Perine probe, at the end of the BOOST implant insertion procedure

  24 hours

Secondary Outcomes (11)

• Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires

  12 months

• Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry

  12 months

• Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score

  12 months

• To assess the efficacy of the treatment at M6 and M12.

  12 months

• To check the absence of overdose in the prostate at D0 and M1.

  1 month

Study Arms (1)

Intervention

EXPERIMENTAL

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

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

Interventions

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

Target dose supplement with the TRINITY® PERINE 3D system

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator
• Koelis: collaborator

Study Sites (1)

Isabelle Boudry

Grenoble, 38043, France

Location

Related Links

• Centre d'Investigation Clinique Innovation Technologique

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Iodine-125

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Carole Iriard, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: April 11, 2022
• Study Start: April 4, 2023
• Primary Completion: July 25, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (1)