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

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Apr 1, 2022

Keywords

ClinConnect Summary

The FOCUS-Boost trial is studying a new way to treat prostate cancer using a method called brachytherapy, where small radioactive seeds (iodine-125) are implanted directly into the prostate. This trial aims to improve the accuracy of the implant procedure by using advanced 3D imaging technology to ensure the seeds are placed precisely in the cancerous areas of the prostate. This is especially important for patients with low or favorable intermediate risk prostate cancer.

To participate in this trial, men aged 18 and older with specific types of prostate cancer may be eligible, as long as they have a life expectancy of over 10 years and certain health criteria are met. Participants will receive brachytherapy treatment and will be carefully monitored during the process. It's essential for potential participants to understand that those with certain health conditions or more aggressive cancer types will not qualify for this study. If you or a loved one is interested, it's a good idea to discuss it with your healthcare provider to see if this trial might be a suitable option.

Gender

MALE

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)