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Trial Title:
Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
NCT ID:
NCT05714774
Condition:
Prostatic Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostatic Neoplasms
HIFU
Focal One
Prostate cancer
focal treatment
total ablation
hemi ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
HIFU treatment of prostate cancer
Description:
HIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional
ultrasound images before, between, and after HIFU shots will be performed.
Arm group label:
Patients with localized prostate cancer
Summary:
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.
Criteria for 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
Gender:
Male
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Address:
City:
Lyon
Zip:
69003
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien Crouzet, Pr
Phone:
04 72 11 03 25
Phone ext:
+33
Email:
Sebastien.crouzet@chu-lyon.fr
Contact backup:
Last name:
Marjolaine Beaudoin, Msc
Phone:
0472117494
Phone ext:
+33
Email:
Marjolaine.beaudoin@chu-lyon.fr
Investigator:
Last name:
Sébastien Crouzet, Pr
Email:
Principal Investigator
Investigator:
Last name:
Marc COLOMBEL, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Olivier ROUVIERE, Pr
Email:
Sub-Investigator
Start date:
March 9, 2023
Completion date:
April 14, 2025
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Collaborator:
Agency:
EDAP TMS S.A.
Agency class:
Industry
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714774
