RECRUITING

HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-09-26
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03620786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 40 years to 85 years
  2. 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. 3. PSA ≤ 20
  4. 4. Prostate volume of ≤ 70 cc
  5. 5. Ability to complete informed consent form
  1. 1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  2. 2. Medical contraindication to follow-up mpMRI or prostate biopsy
  3. 3. Unable to tolerate general or regional anesthesia
  4. 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.)

Contacts and Locations

Study Contact

Merdie Delfin, MSN, NP
CONTACT
(310) 794-3070
Michelle Cardenas, MSN, RN
CONTACT
310-794-3070
mccardenas@mednet.ucla.edu

Principal Investigator

Leonard Marks, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Leonard Marks, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-26
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2018-09-26
Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer