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HIFU for Focal Ablation of Prostate Tissue: An Observational Study

RECRUITINGSponsored by University of California, Los Angeles
Actively Recruiting
SponsorUniversity of California, Los Angeles
Started2018-09-26
Est. completion2027-01-31
Eligibility
Age40 Years – 85 Years
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT03620786

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.

Eligibility

Age: 40 Years – 85 YearsSex: MALEHealthy volunteers accepted
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.)

Conditions2

CancerProstate Cancer

Locations1 site

University of California, Los Angeles
Los Angeles, California, 90095
Leonard Marks, MD

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