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

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT05322356

2021-A01178-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

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