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High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer

2014-08-27 03:18:57 | BioPortfolio

Summary

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.

Description

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

laboratory biomarker analysis, questionnaire administration, assessment of therapy complications, high-intensity focused ultrasound ablation, quality-of-life assessment

Location

University College Hospital - London
London
England
United Kingdom
WIT 3AA

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:57-0400

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