HIFU for Focal Ablation of Prostate Tissue: an Observational Study

About

Brief 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.

Study Type

Observational

Phase

Pilot/Feasibility

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

85 Years

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.)

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