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

Prostate Cancer Clinical Trial

— FOCUS-BOOST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322356
• Other study ID #: 2021-A01178-33
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Grenoble
• Contact: Carole Iriard, MD
• Phone: +334 76 76 54 35
• Email: ciriart[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Isabelle Boudry	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, Koelis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry	Assessment of toxicity by urinary flowmetry	12 months
Secondary	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
Secondary	To assess the efficacy of the treatment at M6 and M12.	PSA (Prostate Specific Antigen) test	12 months
Secondary	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
Secondary	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
Secondary	Dose to CTV-dosi at 150%	V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0	1 month
Secondary	Assess quality of life (inclusion, M1, M3, M6, M12).	QLQ-C30 (Quality of Life Questionnaire) score	12 months
Secondary	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
Secondary	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
Secondary	(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

External Links

•   Centre d'Investigation Clinique Innovation Technologique