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RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells.
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
laboratory biomarker analysis, questionnaire administration, assessment of therapy complications, high-intensity focused ultrasound ablation, quality-of-life assessment
University College Hospital - London
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:18:57-0400
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