OBJECTIVES:
Primary
* To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.
* To evaluate the quality of life of patients treated with this regimen.
Secondary
* To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.
* To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.
* To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.
OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease.
Blood samples and prostate biopsies are collected periodically for further analysis.
Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.