Prostate Cancer Clinical Trial
Official title:
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to
kill tumor cells.
PURPOSE: This phase II trial is studying the side effects of high-intensity focused
ultrasound focal ablation and to see how well it works in treating patients with progressive
prostate cancer.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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