Pivotal Study of the Sonablate® 500 HIFU Treatment of Localized Prostate Cancer
The purpose of the study is to determine the effectiveness of the Sonablate® 500 using high intensity focused ultrasound (HIFU) to treat localized prostate cancer.
Total Enrollment: 466
The standard treatments of prostate cancer are associated with significant morbidity. Less invasive approaches are being investigated to minimize the adverse events associated with the current standard of care. One of these approaches uses high intensity focused ultrasound (HIFU) to ablate the entire prostate gland using a transrectal probe. The HIFU application results in coagulative necrosis of tissue within the focal zone of the probe. The proposed study is a prospective, non-randomized concurrently controlled study of the Sonablate® 500 (SB-500) medical device for the treatment of low risk, localized (T1c/T2a) prostate cancer using HIFU.
Comparisons: The control for the study will utilize the Cryocare® device (Endocare, Irvine CA) for cryoablation of the prostate. The sites enrolling subjects for the cryoablation arm are geographically separated from the sites enrolling subjects for the SB-500 arm. The safety and effectiveness of the SB-500 arm will be compared with the cryoablation arm.
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