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

NCT06375629 | Terminated

• 1 other identifier: EDAP TMS
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Evaluation of adverse events

  using the Clavien-Dindo classification

  1 year

• Evaluation of quality of life

  IQL questionnaires

  3, 6, 9 and 12 months

• Evaluation of urinary incontinence

  ICIQ questionnaire

  3, 6, 9 and 12 months

• Erectile function assessment

  IIEF-5 questionnaire

  3, 6, 9 and 12 months

• Urinary Symptoms

  IPSS questionnaire

  3, 6, 9 and 12 months

Interventions

FocalOne DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (5)

Hospital Universitario Puerta del Mar

Cadiz, 21 11009, Spain

Location

Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo

Madrid, 46 28007, Spain

Location

Hospital Universitario Central De Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Marqués De Valdecilla

Santander, 39008, Spain

Location

Hospital Consorcio General Universitario de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 19, 2024
• Study Start: April 20, 2023
• Primary Completion: January 3, 2025
• Study Completion: March 14, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)