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

Phase 2

• Conditions: Prostate Cancer

• Registration Number: NCT00987675
• Lead Sponsor: University College London Hospitals

Brief Summary

RATIONALE: High-intensity focused ultrasound 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 ablation and to see how well it works in treating patients with progressive prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.

Secondary

* To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.

* To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.

* To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.

OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.

Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.

After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

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: 2011-03
• Primary Completion: 2011-07
• 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
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients requiring androgen blockade at 12 months
Success of treatment as demonstrated by the absence of cancer at 6 months
PSA kinetics after completion of treatment

Trial Locations

Locations (1)

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