RecruitingNot Applicable

HIFU for Focal Ablation of Prostate Tissue: An Observational Study

United States100 participantsStarted 2018-09-26

Plain-language 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.

Who can participate

Age range40 Years – 85 Years

SexMALE

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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.)

What they're measuring

Oncological Response

Timeframe: 6 months

Trial details

NCT IDNCT03620786

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-31

Contact for this trial

Michelle C Cardenas, MSN, NP

(310) 794-3070 mccardenas@mednet.ucla.edu

View on ClinicalTrials.gov More Prostate Cancer trials