Recruiting NCT07645872
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 5 centers
- Hôpital privé Aix en provence — Aix-en-Provence
- Clinique Saint vincent — Besançon
- Hôpital Civil Colmar — Colmar
- Hôpital Edouard Heriot — Lyon
- Clinique Nantes Atlantis — Nantes
Identifiers
NCT: NCT07645872 · HIFU/EU/22.02