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NCT Number: NCT05322356

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Isabelle Boudry

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

Target dose supplement with the TRINITY® PERINE 3D system

Primary outcomes

  1. 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.

    Time frame: 24 hours

    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 outcomes

  1. Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires

    Time frame: 12 months

    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)

  2. Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry

    Time frame: 12 months

    Assessment of toxicity by urinary flowmetry

  3. Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score

    Time frame: 12 months

    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

  4. To assess the efficacy of the treatment at M6 and M12.

    Time frame: 12 months

    PSA (Prostate Specific Antigen) test

  5. To check the absence of overdose in the prostate at D0 and M1.

    Time frame: 1 month

    V150% < 60% of prostate volume on CT dosimetry at D0 and 1 month

  6. To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.

    Time frame: 1 month

    Absence of overdose in organs at risk on scanner dosimetry

  7. Dose to CTV-dosi at 150%

    Time frame: 1 month

    V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0

  8. Assess quality of life (inclusion, M1, M3, M6, M12).

    Time frame: 12 months

    QLQ-C30 (Quality of Life Questionnaire) score

  9. Assess sexual health (inclusion, M1, M3, M6, M12).

    Time frame: 12 months

    IIEF5 questionnaire score (Erectile dysfunction severe (score 5-10), moderate (11-15), mild (16-20), normal erectile function (21-25) and uninterpretable (1-4)).

  10. 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).

    Time frame: 24 hours

    Duration of the entire procedure, the additional procedure (BOOST), and the final ultrasound acquisition at the end of the procedure (when performed)

  11. (For the last 5 patients): Estimate the quality of the registration after insertion of the implants.

    Time frame: 24 hours

    (For the last 5 patients): Final ultrasound acquisition performed at the end of the procedure with the Trinity® Perine system

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network
  • Koelis

Registry information

Official study 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

Acronym: FOCUS-BOOST

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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