ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer (ES-HIFU)

April 16, 2024 updated by: EDAP TMS S.A.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cadiz, Spain, 21 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
      • Madrid, Spain, 46 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo
        • Contact:
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques De Valdecilla
        • Contact:
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital Consorcio General Universitario de Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients newly diagnosed with localized prostate cancer and eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of adverse events
Time Frame: 1 year
using the Clavien-Dindo classification
1 year
Evaluation of quality of life
Time Frame: 3, 6, 9 and 12 months
IQL questionnaires
3, 6, 9 and 12 months
Evaluation of urinary incontinence
Time Frame: 3, 6, 9 and 12 months
ICIQ questionnaire
3, 6, 9 and 12 months
Erectile function assessment
Time Frame: 3, 6, 9 and 12 months
IIEF-5 questionnaire
3, 6, 9 and 12 months
Urinary Symptoms
Time Frame: 3, 6, 9 and 12 months
IPSS questionnaire
3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EDAP TMS S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDAP TMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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