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

N/AActive Not RecruitingNCT05322356

University Hospital, Grenoble15 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

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

Target dose supplement with the TRINITY® PERINE 3D system

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Isabelle Boudry

Grenoble, France

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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

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)

Time frame: 12 months

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

Assessment of toxicity by urinary flowmetry

Time frame: 12 months

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

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

Time frame: 12 months

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

Data from ClinicalTrials.gov

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