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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 Ultrasound System

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Target dose supplement with the TRINITY® PERINE 3D system<br>|

What is the study measuring?
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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. | 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 |
| --- | --- | --- |
| 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) | 12 months | 
| Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry | Assessment of toxicity by urinary flowmetry | 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 | 12 months | 
| To assess the efficacy of the treatment at M6 and M12. | PSA (Prostate Specific Antigen) test | 12 months | 
| To check the absence of overdose in the prostate at D0 and M1. | 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. | Absence of overdose in organs at risk on scanner dosimetry | 1 month | 
| Dose to CTV-dosi at 150% | V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0 | 1 month | 
| Assess quality of life (inclusion, M1, M3, M6, M12). | QLQ-C30 (Quality of Life Questionnaire) score | 12 months | 
| Assess sexual health (inclusion, M1, M3, M6, M12). | 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). | 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. | (For the last 5 patients): Final ultrasound acquisition performed at the end of the procedure with the Trinity® Perine system | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system