Recruiting NCT05714774

Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment

No phase Interventional Prostatic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: HIFU treatment of prostate cancer.
Who it may be relevant to: Registry conditions: Prostatic Neoplasms. Basic parameters: from 50 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
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Official title

Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment Feasibility Study

Overview

The ELASTO-US study is a single center feasibility study to evaluate 3 methods of analyzing real-time ultrasound images acquired during High Intensity Focused Ultrasound (HIFU) treatment in patients with localized prostate cancer. 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.

Interventions

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.

Primary outcome measures

The percentage of analyses that could be completed for each of the three HIFU necrosis detection techniques [Time frame: At day 0]

Secondary outcome measures (6)

To determinate the threshold to differenciate the necrotic area from the non necrotic area [Time frame: at the latest on day 5 after HIFU treatment]
To determinate the threshold to differenciate the partially necrotic area from the non necrotic area [Time frame: at the latest on day 5 after HIFU treatment]
To compare the segmentation of the necrotic zone obtained with the studied parameter to the segmentation obtained with the post treatment MRI [Time frame: at the latest on day 5 after HIFU treatment]
To compare the segmentation of the partially necrotic zone obtained with the studied parameter to the segmentation obtained with the post treatment MRI. [Time frame: at the latest on day 5 after HIFU treatment]
To assess of the impact of patient characteristics and treatment history for prostate cancer. [Time frame: at the latest on day 5 after HIFU treatment]
To assess of the tolerance [Time frame: at the latest on day 5 after HIFU treatment]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

France · 1 center

Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices — Lyon

Identifiers

NCT: NCT05714774 · 69HCL22_0522 · 2022-A01958-35

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗