HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Aug 6, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called High-Intensity Focused Ultrasound (HIFU) for men with prostate cancer. The Sonablate device, which uses HIFU to target and destroy cancerous tissue in the prostate, was approved in the U.S. in 2015. The goal of this research is to gather information about how well HIFU works and how it affects patients' quality of life. This means the study will look at medical data and ask participants questions about their health and daily life after receiving this treatment.

To participate in this trial, men aged 40 to 85 who have chosen HIFU as their treatment for prostate cancer can sign up. They should have a prostate-specific antigen (PSA) level of 20 or lower and a prostate size of no more than 70 cubic centimeters. However, men who have had prior treatments for prostate cancer, have certain medical conditions, or cannot tolerate anesthesia may not be eligible. Participants can expect to be monitored closely during the study and will complete questionnaires about their health to help researchers understand the impact of HIFU on their lives.

Gender

MALE

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.)