NCT00988130

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

HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Sexual Dysfunction

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	high-intensity focused ultrasound ablation
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2009-07-01
• First posted: 2009-10-01
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom