Clinical trial NCT05322356: Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Interstitial brachytherapy
Iodine 125 implant
3D TRINITY® Perine system
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: Koelis
First posted: 2022-04-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
measure: Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires
timeFrame: 12 months
measure: Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry
timeFrame: 12 months
measure: Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score
timeFrame: 12 months
measure: To assess the efficacy of the treatment at M6 and M12.
timeFrame: 12 months
measure: To check the absence of overdose in the prostate at D0 and M1.
timeFrame: 1 month
measure: To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.
timeFrame: 1 month
measure: Dose to CTV-dosi at 150%
timeFrame: 1 month
measure: Assess quality of life (inclusion, M1, M3, M6, M12).
timeFrame: 12 months
measure: Assess sexual health (inclusion, M1, M3, M6, M12).
timeFrame: 12 months
measure: 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).
timeFrame: 24 hours
measure: (For the last 5 patients): Estimate the quality of the registration after insertion of the implants.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Isabelle Boudry
Study officials:
affiliation: University Hospital, Grenoble
name: Carole Iriard, MD
role: PRINCIPAL_INVESTIGATOR
References: