Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
NCT ID: NCT05714774
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-03-09
2025-04-14
Brief Summary
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Real-time ultrasound acquisitions will be programmed at specific times and recorded during HIFU treatment. At the end of the treatment, these recordings will be exported in an anonymized way and analyzed according to the 3 different methods.
A multiparametric-MRI will be performed in addition to the usual practice within 5 days after the treatment in order to control the area necroticised by the treatment. The mp-MRI will be the reference method against which the results obtained by the 3 methods of ultrasound image analysis will be compared.
Techniques capable of providing safe and robust information on the progress of HIFU-generated necrosis would greatly limit the risks of overtreatment that can lead to side effects such as urinary incontinence as well as the risks of under treatment that can lead to cancer recurrence.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with localized prostate cancer
Patients with localized prostate cancer for which focal treatment, hemi-ablation or total ablation of the prostate is indicated will be treated by HIFU applied by FocalOne device.
HIFU treatment of prostate cancer
HIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional ultrasound images before, between, and after HIFU shots will be performed.
Interventions
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HIFU treatment of prostate cancer
HIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional ultrasound images before, between, and after HIFU shots will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
MALE
No
Sponsors
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EDAP TMS S.A.
INDUSTRY
Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Sébastien Crouzet, Pr
Role: PRINCIPAL_INVESTIGATOR
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Locations
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Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01958-35
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL22_0522
Identifier Type: -
Identifier Source: org_study_id
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