Precision prostate cancer treatment using 3D imaging for targeted brachytherapy
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
NA · University Hospital, Grenoble · NCT05322356
This study is testing a new way to treat prostate cancer using 3D imaging to deliver targeted radiation directly to tumors while reducing radiation exposure to healthy areas.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05322356 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the treatment of prostate cancer through interstitial brachytherapy using iodine-125 implants. By employing the TRINITY® PERINE 3D ultrasound image fusion system, the study seeks to accurately deliver a higher dose of radiation directly to the tumor volume identified by positive biopsies. This approach is designed to improve disease control while minimizing the overall radiation exposure to the prostate. The trial will involve patients with low to favorable intermediate risk prostate adenocarcinoma who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with low or favorable intermediate risk prostate adenocarcinoma and specific clinical characteristics.
Not a fit: Patients with high-risk prostate cancer, significant urinary function disorders, or those with a prostate volume exceeding 60 cc may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved disease control and reduced recurrence rates for prostate cancer patients.
How similar studies have performed: Other studies utilizing advanced imaging techniques for targeted brachytherapy have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Grenoble
- Isabelle Boudry — Grenoble, France (RECRUITING)
Study contacts
- Principal investigator: Carole Iriard, MD — University Hospital, Grenoble
- Study coordinator: Carole Iriard, MD
- Email: ciriart@chu-grenoble.fr
- Phone: +334 76 76 54 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system