Active — Not RecruitingNot Applicable

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

France15 participantsStarted 2023-04-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05322356

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-25

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