Prostate CancerES-HIFUNCT06375629
ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer
An observational study of Prostate Cancer, run by EDAP TMS S.A. at 5 sites in Spain.
Trial summary
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. 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?
- FocalOne
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 5 sitesSpain
- Study dates
- 20 Apr 2023to 14 Mar 2025
- Phase
- Observational
- 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
Study population: Patients newly diagnosed with localized prostate cancer and eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
Who may be able to join
- Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
- Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
- Gleason ≤ 4+3.
- Patient scheduled for HIFU treatment as determined by the physician.
- Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent
Who cannot join
- Patient with bilateral prostate cancer requiring whole gland treatment.
- Patients clinically detected metastasis.
- Patient with an extension of cancer or seminal vesicle invasion.
- Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario Puerta del Mar
Cadiz, 21 11009
Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo
Madrid, 46 28007
Hospital Universitario Central De Asturias
Oviedo, 33011
Hospital Universitario Marqués De Valdecilla
Santander, 39008
Hospital Consorcio General Universitario de Valencia
Valencia, 46014
About this study
Official title: A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.
- Conditions
- Prostate Cancer
- Being tested
- FocalOne
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FocalOneDevice
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. This study is a non-interventional study. All the data will be collected from routine care. Data as indicated in the table below will be systematically recorded on the e-CRF to coincide with the scheduled follow-up visits at 3, 6 and 12 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse events
using the Clavien-Dindo classification
Measured: 1 year
Evaluation of quality of life
IQL questionnaires
Measured: 3, 6, 9 and 12 months
Evaluation of urinary incontinence
ICIQ questionnaire
Measured: 3, 6, 9 and 12 months
Erectile function assessment
IIEF-5 questionnaire
Measured: 3, 6, 9 and 12 months
Urinary Symptoms
IPSS questionnaire
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Apr 2023
- Primary completion3 Jan 2025
- Study completion14 Mar 2025
Why it stopped: The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375629
- Sponsor's protocol ID
- EDAP TMS
- Acronym
- ES-HIFU
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer
- ClinicalTrials.gov ID
- NCT06375629
- Acronym / sponsor ID
- ES-HIFU / EDAP TMS
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 19 Apr 2024 (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 objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with localized prostate cancer and eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
Key inclusion criteria (5 listed)
- Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
- Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
- Gleason ≤ 4+3.
- Patient scheduled for HIFU treatment as determined by the physician.
- Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent
Key exclusion criteria (4 listed)
- Patient with bilateral prostate cancer requiring whole gland treatment.
- Patients clinically detected metastasis.
- Patient with an extension of cancer or seminal vesicle invasion.
- Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.
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 |
|---|---|---|
| FocalOneThe objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. This study is a non-interventional study. All the data will be collected from routine care. Data as indicated in the table below will be systematically recorded on the e-CRF to coincide with the scheduled follow-up visits at 3, 6 and 12 months. | Device | – |
Primary outcome
Evaluation of adverse events
Time frame: 1 year
using the Clavien-Dindo classification
Evaluation of quality of life
Time frame: 3, 6, 9 and 12 months
IQL questionnaires
Evaluation of urinary incontinence
Time frame: 3, 6, 9 and 12 months
ICIQ questionnaire
Erectile function assessment
Time frame: 3, 6, 9 and 12 months
IIEF-5 questionnaire
Urinary Symptoms
Time frame: 3, 6, 9 and 12 months
IPSS questionnaire
Results and safety
The study was stopped early (reason given: The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by EDAP TMS S.A. at 5 sites in Spain.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 was stopped early (reason given: The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.). Results are not available in the source record.
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?
Evaluation of adverse events (time frame: 1 year). The study lists 5 primary outcomes in all. 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 2 Apr 2025.