Evaluating ultrasound methods for monitoring prostate cancer treatment
Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment Feasibility Study
This study is testing three different ways to use ultrasound images during prostate cancer treatment to see which method best helps doctors track how well the treatment is working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05714774 on ClinicalTrials.gov |
What this trial studies
This study evaluates three different methods of analyzing real-time ultrasound images during High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer. The ultrasound images will be recorded at specific intervals during the treatment and later analyzed to assess their effectiveness in monitoring treatment progress. A multiparametric MRI will be conducted shortly after treatment to compare the results of the ultrasound analysis methods against a reference standard. The goal is to improve monitoring techniques to reduce the risks of overtreatment and associated side effects.
Who should consider this trial
Good fit: Ideal candidates include males aged 50 and older with localized prostate cancer and specific clinical criteria.
Not a fit: Patients with contraindications to HIFU treatment or those with advanced disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of HIFU treatment for prostate cancer, potentially reducing side effects like urinary incontinence.
How similar studies have performed: While the approach of using ultrasound for real-time monitoring is established, the specific methods being evaluated in this study are novel and have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who has been clearly informed of the study and has agreed, with sufficient time for reflection, to participate by signing the study informed consent form. * Male aged ≥ 50 years, * PSA ≤ 15 ng/mL * diagnosis of localized prostate cancer (stage T1 or T2) with a Gleason score of ≤ 7 * Focal, hemiablation or ablation HIFU treatment validated in Multidisciplinary Concerted Meeting * Patient enrolled in Medicare or equivalent plan. * Interpretable preoperative multiparametric MRI performed within 180 days prior to surgery Exclusion Criteria: * an ASA score \>3 * brachytherapy for prostate cancer * Person of full age protected by law (person under guardianship or curatorship). * Contraindication to HIFU treatment as defined in the Focal One instructions for use : - Multiple intraprostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and therefore the realization of the treatment. * Presence of permanent radioactive implants in the rectal wall. * Presence of an implant (stent, catheter) located less than 1 cm from the treatment area. * Fistula of the urinary tract or rectum. * Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making insertion of the Focal One® catheter difficult. * Anatomical abnormality of the rectum or rectal mucosa. * Patient with an artificial sphincter, penile prosthesis or intraprostatic implant, such as a stent. * History of inflammatory bowel disease. * Current urogenital infection (infection should be treated prior to HIFU treatment). * Patient allergic to latex with known severe reactionsCounter-indications to anesthesia
Where this trial is running
Lyon
- Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Sébastien Crouzet, Pr — Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
- Study coordinator: Sébastien Crouzet, Pr
- Email: Sebastien.crouzet@chu-lyon.fr
- Phone: 04 72 11 03 25
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.