NCT00561262

High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer

An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: 79 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue. PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.

Detailed description

OBJECTIVES: Primary * To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events. * To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit. Secondary * To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure. * To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue. * To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir. * To determine the effectiveness of therapy by recording the need for secondary or adjuvant treatment following therapy. OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side of the prostate with cancer and up to 5 mm over into the contralateral side to ensure adequacy. Patients complete questionnaires periodically during study to assess urinary symptoms and erectile dysfunction. These include the International Index of Erectile Function-15 \[IIEF-15\]; the International Prostate Symptom Score \[IPSS\] and IPSS-QoL; the Functional Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire. After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1, 3, 6, 9, and 12 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	high-intensity focused ultrasound ablation
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-10-01
• Completion: 2011-04-01
• First posted: 2007-11-20
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom