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NCT Number: NCT07645872

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital privé Aix en provence, Aix-en-Provence, France

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About this study

It is a prospective and retrospective register.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. PSA values after HIFU treatment

    Time frame: 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.

  2. Incidence of local recurrence detected by prostate MRI after HIFU treatment

    Time frame: 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.

  3. Prostate biopsy results after HIFU treatment

    Time frame: 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.

  4. To estimate the retreatment rate of patients treated with HIFU

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Djamila BENNAT

CONTACT

[email protected]

+33 472153150

Léa GUEDJ

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Registry information

Acronym: One registry

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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