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

Prostate Cancer Clinical Trial

— ES-HIFU  

Official title:

A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375629
• Other study ID #: EDAP TMS
• Status: Recruiting
• Start date: April 20, 2023
• Est. completion date: April 20, 2027

Study information

• Verified date: March 2024
• Source: EDAP TMS S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 20, 2027
• Est. primary completion date: April 20, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• FocalOne
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. This study is a non-interventional study. All the data will be collected from routine care. Data as indicated in the table below will be systematically recorded on the e-CRF to coincide with the scheduled follow-up visits at 3, 6 and 12 months.

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo	Madrid
Spain	Hospital Universitario Central De Asturias	Oviedo
Spain	Hospital Universitario Marqués De Valdecilla	Santander
Spain	Hospital Consorcio General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
EDAP TMS S.A.

Country where clinical trial is conducted

Spain, 

Outcome

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