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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years
  • Patient to be treated with brachytherapy
  • Patient with low or 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) < 20 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 ≥ 20 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)

Sites / Locations

  • Isabelle BoudryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2021
Last Updated
February 16, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Koelis
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1. Study Identification

Unique Protocol Identification Number
NCT05322356
Brief Title
Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Koelis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
Intervention Description
Target dose supplement with the TRINITY® PERINE 3D system
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires
Description
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
Title
Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry
Description
Assessment of toxicity by urinary flowmetry
Time Frame
12 months
Title
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score
Description
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
Title
To assess the efficacy of the treatment at M6 and M12.
Description
PSA (Prostate Specific Antigen) test
Time Frame
12 months
Title
To check the absence of overdose in the prostate at D0 and M1.
Description
V150% < 60% of prostate volume on CT dosimetry at D0 and 1 month
Time Frame
1 month
Title
To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.
Description
Absence of overdose in organs at risk on scanner dosimetry
Time Frame
1 month
Title
Dose to CTV-dosi at 150%
Description
V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0
Time Frame
1 month
Title
Assess quality of life (inclusion, M1, M3, M6, M12).
Description
QLQ-C30 (Quality of Life Questionnaire) score
Time Frame
12 months
Title
Assess sexual health (inclusion, M1, M3, M6, M12).
Description
IIEF5 questionnaire score (Erectile dysfunction severe (score 5-10), moderate (11-15), mild (16-20), normal erectile function (21-25) and uninterpretable (1-4)).
Time Frame
12 months
Title
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).
Description
Duration of the entire procedure, the additional procedure (BOOST), and the final ultrasound acquisition at the end of the procedure (when performed)
Time Frame
24 hours
Title
(For the last 5 patients): Estimate the quality of the registration after insertion of the implants.
Description
(For the last 5 patients): Final ultrasound acquisition performed at the end of the procedure with the Trinity® Perine system
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Iriard, MD
Phone
+334 76 76 54 35
Email
ciriart@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Boudry, PhD
Phone
+33476766645
Email
iboudry@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Iriard, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isabelle Boudry
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Boudry, PhD
Phone
+33476766645
Email
iboudry@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Carole Iriart, Dr

12. IPD Sharing Statement

Links:
URL
https://www.cic-it.fr/cic-it-grenoble.php
Description
Centre d'Investigation Clinique Innovation Technologique

Learn more about this trial

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

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