Prostatic NeoplasmsELASTO-USNCT05714774
Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
A study testing HIFU treatment of prostate cancer in people with Prostatic Neoplasms, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- HIFU treatment of prostate cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69003
Sébastien Crouzet, Pr, 04 72 11 03 25 ext. +33, Sebastien.crouzet@chu-lyon.fr
Marjolaine Beaudoin, Msc, 0472117494 ext. +33, Marjolaine.beaudoin@chu-lyon.fr
About this study
Official title: Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment Feasibility Study
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.
Read more
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.
- Conditions
- Prostatic Neoplasms
- Being tested
- HIFU treatment of prostate cancer
- Keywords
- Prostatic Neoplasms, HIFU, Focal One, Prostate cancer, focal treatment, total ablation, hemi ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatment of prostate cancerDevice
HIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional ultrasound images before, between, and after HIFU shots will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with localized prostate cancer | Experimental | 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. Receives: Device: HIFU treatment of prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of analyses that could be completed for each of the three HIFU necrosis detection techniques
To determine the feasibility of implementing the Gray Level Histogram, The Nakagami imaging and proposed in this study, different factors will take into account : the quality of the acquired ultrasound images, the quality of the ultrasound image registration and the quality of the MRI image registration.
The implementation of passive elastography, one of the three new methods proposed in this study, requires the presence of a sufficient wavefield in the tissue under study. An ultrasound expert will evaluate this aspect and determine whether or not the mechanical properties of the tissue can be assessed by passive elastography.
Measured: At day 0
Secondary outcomes (6)
To determinate the threshold to differenciate the necrotic area from the non necrotic area
The threshold of the necrotic area will be determined by optimizing the sensitivity/specificity between voxels (necrotic, partially necrotic or non-necrotic).
On post-op MRI, the prostate volume will be cut into voxels where each voxel will be classified according to its level of necrosis (total, partial or non-necrotic) by an expert radiologist.
Measured: at the latest on day 5 after HIFU treatment
To determinate the threshold to differenciate the partially necrotic area from the non necrotic area
The threshold of the necrotic area will be determined by optimizing the sensitivity/specificity between voxels (necrotic, partially necrotic or non-necrotic).
On post-op MRI, the prostate volume will be cut into voxels where each voxel will be classified according to its level of necrosis (total, partial or non-necrotic) by an expert radiologist.
Measured: 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
The Hausdorff distance, which evaluates the similarity with necrotic areas on post-op MRI, will be calculated for each parameter, for each patient and for each of the two segmentation modalities. A total of 12 Hausdorff distances per patient.
Measured: 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.
The Hausdorff distance, which evaluates the similarity with necrotic areas on post-op MRI, will be calculated for each parameter, for each patient and for each of the two segmentation modalities. A total of 12 Hausdorff distances per patient.
Measured: at the latest on day 5 after HIFU treatment
To assess of the impact of patient characteristics and treatment history for prostate cancer.
The segmentations obtained with the studied parameter will be analyzed with respect to the following patient characteristics:
- Pre-treatment prostate volume.
- Treatment strategy (focal, hemi or total ablation)
- Treatment history (primary or retreatment)
- Possible associated surgical procedures (TURP, incision, ...)
- Gleason score of the tumor
Measured: at the latest on day 5 after HIFU treatment
To assess of the tolerance
The tolerance of the treatment will be evaluated by recording the adverse events that occurred during the patient follow-up with regard to the prolongation of the anaesthesia (approximately 20 minutes) and the realization of the mp MRI with postoperative contrast injection
Measured: at the latest on day 5 after HIFU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start9 Mar 2023
- Primary completion14 Apr 2025 (estimated)
- Study completion14 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- EDAP TMS S.A.
- Responsible party
- Sponsor
- Investigators
- Sébastien Crouzet, Pr, Principal investigator, Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714774
- Sponsor's protocol ID
- 69HCL22_0522
- Other IDs
- 2022-A01958-35
- Acronym
- ELASTO-US
- Status last verified
- Sep 2024
- First submitted
- 27 Jan 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment Feasibility Study
- ClinicalTrials.gov ID
- NCT05714774
- Acronym / sponsor ID
- ELASTO-US / 69HCL22_0522
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic Neoplasms, HIFU, Focal One, Prostate cancer, focal treatment, total ablation, hemi ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- EDAP TMS S.A.
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 14 Apr 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with localized prostate cancer | Experimental | Device: HIFU treatment of prostate cancerPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU treatment of prostate cancerHIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional ultrasound images before, between, and after HIFU shots will be performed. | Device | Patients with localized prostate cancer |
Primary outcome
The percentage of analyses that could be completed for each of the three HIFU necrosis detection techniques
Time frame: At day 0
To determine the feasibility of implementing the Gray Level Histogram, The Nakagami imaging and proposed in this study, different factors will take into account : the quality of the acquired ultrasound images, the quality of the ultrasound image registration and the quality of the MRI image registration. The implementation of passive elastography, one of the three new methods proposed in this study, requires the presence of a sufficient wavefield in the tissue under study. An ultrasound expert will evaluate this aspect and determine whether or not the mechanical properties of the tissue can be assessed by passive elastography.
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Crouzet, Pr principal investigator
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment of prostate cancer in people with Prostatic Neoplasms, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Crouzet, Pr (04 72 11 03 25 ext. +33, Sebastien.crouzet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of analyses that could be completed for each of the three HIFU necrosis detection techniques (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.