Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07645872

Acronym

One registry

Enrollment

3000

Registered

2026-06-12

Start date

2023-02-01

Completion date

2031-04-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

Detailed description

It is a prospective and retrospective register.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Patient deprived of liberty following a judicial or administrative decision * Patient under guardianship or curatorship \* if applicable according to local regulation

Design outcomes

Primary

Measure	Time frame	Description
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.	From HIFU treatment up to 5 years post-HIFU	Safety will be assessed by collecting adverse events related to HIFU treatment.

Secondary

Measure	Time frame	Description
PSA values after HIFU treatment	From HIFU treatment up to 5 years post-HIFU	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.
Incidence of local recurrence detected by prostate MRI after HIFU treatment	From HIFU treatment up to 5 years post-HIFU	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.
Prostate biopsy results after HIFU treatment	From HIFU treatment up to 5 years post-HIFU	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.
To estimate the retreatment rate of patients treated with HIFU	From HIFU treatment up to 5 years post-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.

Countries

France

Contacts

CONTACTDjamila BENNAT

dbennat@edap-tms.com+33 472153150

CONTACTLéa GUEDJ

lguedj@edap-tms.com

Outcome results