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NCT Number: NCT03620786

HIFU for Focal Ablation of Prostate Tissue: An Observational Study

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Leonard Marks, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years to 85 years
  • 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)
  • PSA ≤ 20
  • Prostate volume of ≤ 70 cc
  • Ability to complete informed consent form

Exclusion criteria

  • Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  • Medical contraindication to follow-up mpMRI or prostate biopsy
  • Unable to tolerate general or regional anesthesia
  • 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.)

Treatment and study plan

Sonablate HIFU device

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.

Primary outcomes

  1. Oncological Response

    Time frame: 6 months

    The following definitions will be used for evaluation of oncological response:

    • 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.
    • Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline
    • Local failure: Failure to ablate prostate tissue

Secondary outcomes

  1. Evaluation of Quality-of-Life Symptoms (EPIC-CP)

    Time frame: 6 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.

  2. Evaluation of Quality-of-Life Symptoms (EPIC-CP)

    Time frame: 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.

  3. Decisional Regret Scale

    Time frame: 18 months

    This questionnaire data will be collected to assess for subjects' decision-making satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Ankush sachdeva

CONTACT

[email protected]

310-794-7700

Michelle C Cardenas, MSN, NP

CONTACT

[email protected]

(310) 794-3070

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Aug 8, 2018
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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