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

Phase 2

• Conditions: Prostate Cancer; Sexual Dysfunction

• Registration Number: NCT00988130
• Lead Sponsor: University College London Hospitals

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Status Verified: 2011-05
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total proportion of men with erectile dysfunction and/or incontinence
Quality of life

Secondary Outcome Measures

Name	Time	Method
Success of index lesion ablation with HIFU at 6 months
Prostate-specific antigen kinetics
Proportion of men requiring androgen blockade at 12 months

Trial Locations

Locations (1)

University College Hospital - London; 🇬🇧 London, England, United Kingdom