HIFU for Focal Ablation of Prostate Tissue: An Observational Study

NCT ID: NCT03620786

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2028-01-31

Brief Summary

The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

Detailed Description

This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIFU Study Participants

Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. The HIFU device currently used in this standard-of-care procedure at UCLA is the Sonablate 450 HIFU System.

Sonablate HIFU device

Intervention Type: DEVICE

In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.

Interventions

Sonablate HIFU device

In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 40 years to 85 years

2. Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)

3. PSA ≤ 20

4. Prostate volume of ≤ 70 cc

5. Ability to complete informed consent form

Exclusion Criteria

1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)

2. Medical contraindication to follow-up mpMRI or prostate biopsy

3. Unable to tolerate general or regional anesthesia

4. Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Leonard S. Marks, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonard Marks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Merdie Delfin, MSN, NP

Role: CONTACT

(310) 794-3070

Michelle Cardenas, MSN, RN

Role: CONTACT

mccardenas@mednet.ucla.edu

310-794-3070

Other Identifiers

16-000904

Identifier Type: -

Identifier Source: org_study_id