Prostate CancerIDITOP-1NCT01729442
Assessment of HIFU-induced Prostate Necrosis With Shear-wave Ultrasound Elastography
A study testing Shear-wave ultrasound elastography (SWUE) in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Shear-wave ultrasound elastography (SWUE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Oct 2014
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Prostate cancer proved by biopsy
- Prostate cancer not eligible for surgery referred for total or hemi HIFU ablation, OR prostate cancer local recurrence referred for salvage HIFU ablation
- Anal and rectal normal anatomy
- Life expectancy ≥ 5 years
- Satisfactory general condition (ASA 1 to 3)
- Informed consent signed
- Affiliation to the French social security system or equivalent social security system.
Who cannot join
- Patient treated by hormonotherapy
- Prostatic calcifications preventing HIFU ablation
- Distance between rectal mucosa and prostatic capsule ≥ 6 mm
- History of inflammatory bowel disease
- Sclerosis of the bladder neck or urethral stenosis
- Rectal fistula
Show all 15Show fewer
- Ongoing urinary infection
- Impaired renal function (MDRD < 30mL/min/1,73 m²)
- Severe BPCO
- Acute endocarditis/ Hypercoagulation/ recent thromboembolism
- Latex or sulphur hexafluoride allergy
- Contraindication to the injection of Sonovue®
- Patient on protection of the Court, under supervision or trusteeship
- Inability to express an informed consent
- Patient already enrolled in a study that could interfere with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography
Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy.
It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result.
Read more
CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient.
Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.
The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy.
SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE.
The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS.
The secondary endpoints are:
- The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1,
- Adverse events related to SWUE.
The study will last 40 months.
- Conditions
- Prostate Cancer
- Being tested
- Shear-wave ultrasound elastography (SWUE)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear-wave ultrasound elastography (SWUE)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for first-line prostate HIFU ablation | Other | 10 patients Receives: Other: Shear-wave ultrasound elastography (SWUE) |
| Patients referred for first-line HIFU hemi-ablation | Other | 10 patients Receives: Other: Shear-wave ultrasound elastography (SWUE) |
| Patients referred for salvage HIFU after radiotherapy | Other | 10 patients Receives: Other: Shear-wave ultrasound elastography (SWUE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the thickness of undestroyed parenchyma
Briefly, the thickness of undestroyed parenchyma will be measured on CEUS and D0 SWUE in the anterior, lateral and posterior parts of both prostatic lobes. The thickness (height) of undestroyed parenchyma left at both apex will also be measured.
Measurements obtained with CEUS (used as reference) and SWUE will be compared.
Measured: Day 0
Secondary outcomes (1)
Evolution of shear elasticity in the treated area
Using CEUS images as reference, a Region-of-Interest (ROI) will be placed within the area destroyed by HIFU in both lobes (except for the hemi-HIFU group). The stiffness within the ROI will be measured before HIFU ablation (D-1), immediately after (D0) and the day after (D+1).
One or two ROI will also be placed in undestroyed tissue (as shown by CEUS used as reference) and the evolution of stiffness from D-1 to D+1 will also be measured.
Measured: D-1 / D0 / D+1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Rouvière, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729442
- Sponsor's protocol ID
- 2012.730
- Acronym
- IDITOP-1
- Status last verified
- Oct 2014
- First submitted
- 14 Nov 2012
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography
- ClinicalTrials.gov ID
- NCT01729442
- Acronym / sponsor ID
- IDITOP-1 / 2012.730
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2012 (estimated)
- 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.
Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy.
It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result.
CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient.
Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.
The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy.
SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE.
The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS.
The secondary endpoints are:
- The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1,
- Adverse events related to SWUE.
The study will last 40 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients referred for first-line prostate HIFU ablation | Other | Other: Shear-wave ultrasound elastography (SWUE)10 patients |
| Patients referred for first-line HIFU hemi-ablation | Other | Other: Shear-wave ultrasound elastography (SWUE)10 patients |
| Patients referred for salvage HIFU after radiotherapy | Other | Other: Shear-wave ultrasound elastography (SWUE)10 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Prostate cancer proved by biopsy
- Prostate cancer not eligible for surgery referred for total or hemi HIFU ablation, OR prostate cancer local recurrence referred for salvage HIFU ablation
- Anal and rectal normal anatomy
- Life expectancy ≥ 5 years
Key exclusion criteria (15 listed)
- Patient treated by hormonotherapy
- Prostatic calcifications preventing HIFU ablation
- Distance between rectal mucosa and prostatic capsule ≥ 6 mm
- History of inflammatory bowel disease
- Sclerosis of the bladder neck or urethral stenosis
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 |
|---|---|---|
| Shear-wave ultrasound elastography (SWUE) | Other | Patients referred for first-line HIFU hemi-ablation, Patients referred for first-line prostate HIFU ablation, Patients referred for salvage HIFU after radiotherapy |
Primary outcome
Measurement of the thickness of undestroyed parenchyma
Time frame: Day 0
Briefly, the thickness of undestroyed parenchyma will be measured on CEUS and D0 SWUE in the anterior, lateral and posterior parts of both prostatic lobes. The thickness (height) of undestroyed parenchyma left at both apex will also be measured. Measurements obtained with CEUS (used as reference) and SWUE will be compared.
1 secondary outcome
Evolution of shear elasticity in the treated area
Time frame: D-1 / D0 / D+1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Olivier Rouvière, Pr principal investigator
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 Shear-wave ultrasound elastography (SWUE) in people with Prostate Cancer, 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 22 Oct 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the thickness of undestroyed parenchyma (time frame: 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 22 Oct 2014.