Prostate CancerOne registryNCT07645872
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
An observational study of Prostate Cancer, run by EDAP TMS S.A. at 5 sites in France.
Trial summary
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 3,000 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Feb 2023to Apr 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients Being treated for prostate cancer with the Focal One device
Who may be able to join
- Being treated for prostate cancer with the Focal One device
- Patient does not object and consent* to the collection of clinical data in the registry
Who cannot join
- Patient deprived of liberty following a judicial or administrative decision
- Patient under guardianship or curatorship * if applicable according to local regulation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Léa GUEDJ contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hôpital privé Aix en provence
Aix-en-Provence, 13080
Dr BARRIOL, Dr, +33442331764, david.barriol@gmail.com
David BARRIOL, Dr
- Recruiting
Clinique Saint vincent
Besançon, 25056
Blandine Firek, +33 6 61 70 85 41, blandine.firek@gmail.com
Vincent BAILLY, Dr
- Recruiting
Hôpital Civil Colmar
Colmar, 68000
LOPEZ SANTIAGO, DR, +33 389124520, santiago.lopez@ch-colmar.fr
Santiago LOPEZ, dr
- Recruiting
Hôpital Edouard Heriot
Lyon, 69000
Marjolaine BEAUDOIN, 0(33) 4 72 11 74 94, marjolaine.beaudoin@chu-lyon.fr
Sébastien CROUZET, Pr
- Recruiting
Clinique Nantes Atlantis
Nantes, 44000
Cyrielle REGOIN, +33442331766, cyrielle.leduin@sfr.fr
Eric POTIRON, Dr
About this study
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.
Read the detailed description
It is a prospective and retrospective register.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Safety will be assessed by collecting adverse events related to HIFU treatment.
Measured: From HIFU treatment up to 5 years post-HIFU
Secondary outcomes (4)
PSA values after HIFU treatment
Oncological outcomes will be assessed using PSA measurements obtained as part of routine care. The outcome will be reported as PSA values measured during follow-up after HIFU treatment.
Measured: From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
Local recurrence will be assessed using prostate MRI performed as part of routine care. The outcome will be reported as the number and proportion of patients with imaging findings suspicious for local recurrence.
Measured: From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
Oncological outcomes will be assessed using prostate biopsy results obtained as part of routine care. The outcome will be reported as the number and proportion of patients with positive biopsy findings during follow-up after HIFU treatment.
Measured: From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
The rate and timing of retreatment (radical prostatectomy, radiotherapy, cryotherapy, HIFU, other focal treatment) after HIFU treatment will be assessed using data from the patient's clinical follow-up.
Measured: From HIFU treatment up to 5 years post-HIFU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Feb 2023
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
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
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
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
- NCT07645872
- Sponsor's protocol ID
- HIFU/EU/22.02
- Acronym
- One registry
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
- ClinicalTrials.gov ID
- NCT07645872
- Acronym / sponsor ID
- One registry / HIFU/EU/22.02
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 12 Jun 2026 (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 aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.
Detailed description
It is a prospective and retrospective register.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Being treated for prostate cancer with the Focal One device
Key inclusion criteria (2 listed)
- Being treated for prostate cancer with the Focal One device
- Patient does not object and consent* to the collection of clinical data in the registry
Key exclusion criteria (2 listed)
- Patient deprived of liberty following a judicial or administrative decision
- Patient under guardianship or curatorship * if applicable according to local regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Time frame: From HIFU treatment up to 5 years post-HIFU
Safety will be assessed by collecting adverse events related to HIFU treatment.
4 secondary outcomes
PSA values after HIFU treatment
Time frame: From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
Time frame: From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
Time frame: From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
Time frame: From HIFU treatment up to 5 years post-HIFU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
Léa GUEDJ contact
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 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Djamila BENNAT (+33 472153150, dbennat@edap-tms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer. (time frame: From HIFU treatment up to 5 years post-HIFU). 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 12 Jun 2026.