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

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT06375629
• Lead Sponsor: EDAP TMS S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-20
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Primary Completion: 2025-01-03
• Status Verified: 2025-03
• Study Completion: 2025-03-14
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo; 🇪🇸 Madrid, Spain

Hospital Consorcio General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Central De Asturias; 🇪🇸 Oviedo, Spain

Hospital Universitario Marqués De Valdecilla; 🇪🇸 Santander, Spain