HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Sonablate HIFU device

• Registration Number: NCT03620786
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-08
• Study Start: 2018-09-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2027-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

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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.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIFU Study Participants	Sonablate HIFU device	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.

Primary Outcome Measures

Name	Time	Method
Oncological Response	6 months	The following definitions will be used for evaluation of oncological response: 1. Complete response: Ablation of prostate tissue in targeted biopsy cores at 6 months and 18 months post-procedure biopsy and resolution of initial mp-MRI abnormality.; 2. Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline; 3. Local failure: Failure to ablate prostate tissue

Secondary Outcome Measures

Name	Time	Method
Decisional Regret Scale	18 months	This questionnaire data will be collected to assess for subjects' decision-making satisfaction.
Evaluation of Quality-of-Life Symptoms (EPIC-CP)	18 months	The EPIC-CP questionnaire will be used to evaluate urinary, bowel and sexual health quality-of-life symptoms for participants pre- and post-HIFU.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States