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

April 30, 2026 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Isabelle Boudry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 the French public health code)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 24 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the efficacy of the treatment at M6 and M12.
Time Frame: 12 months
PSA (Prostate Specific Antigen) test
12 months
To check the absence of overdose in the prostate at D0 and M1.
Time Frame: 1 month
V150% < 60% of prostate volume on CT dosimetry at D0 and 1 month
1 month
To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.
Time Frame: 1 month
Absence of overdose in organs at risk on scanner dosimetry
1 month
Assess quality of life (inclusion, M1, M3, M6, M12).
Time Frame: 12 months
QLQ-C30 (Quality of Life Questionnaire) score
12 months
Assess sexual health (inclusion, M1, M3, M6, M12).
Time Frame: 12 months
IIEF5 questionnaire score (Erectile dysfunction severe (score 5-10), moderate (11-15), mild (16-20), normal erectile function (21-25) and uninterpretable (1-4)).
12 months
Measure the duration of the complete procedure, the additional act (BOOST) and the final ultrasound acquisition performed at the end of the procedure (when performed).
Time Frame: 24 hours
Duration of the entire procedure, the additional procedure (BOOST), and the final ultrasound acquisition at the end of the procedure (when performed)
24 hours
(For the last 5 patients): Estimate the quality of the registration after insertion of the implants.
Time Frame: 24 hours
(For the last 5 patients): Final ultrasound acquisition performed at the end of the procedure with the Trinity® Perine system
24 hours
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires
Time Frame: 12 months

Assessment of toxicity by questionnaires (IPSS score + urinary symptom quality of life).

IPSS:: International Prostate Score Symptom (0 to 35: Score 20-35: severely symptomatic. Score 8-19: moderately symptomatic)
12 months
Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry
Time Frame: 12 months
Assessment of toxicity by urinary flowmetry
12 months
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score
Time Frame: 12 months
Assessment of toxicity by classification of toxicities according to CTCAE score (Common Terminology Criteria for Adverse Events: Grade 1 Mild / Grade 2 Moderate / Grade 3 Severe or medically significant but not immediately life-threatening / Grade 4 Life-threatening consequences / Grade 5 Death related to A
12 months
Dose to CTV-dosi at 150%
Time Frame: 1 month
V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Clinical Investigation Centre for Innovative Technology Network
Koelis

Investigators

  • Principal Investigator: Carole Iriard, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Actual)

July 25, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01178-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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