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

August 23, 2013 updated by: University College London Hospitals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, WIT 3AA
        • Recruiting
        • University College Hospital - London
        • Contact:
          • Mark Emberton, MD, FRCS, MBBS
          • Phone Number: 44-20-7380-9194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies

    • Stage ≤ T3bN0M0
    • Gleason grade ≤ 8
    • Serum PSA ≤ 20 ng/mL
    • Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease
    • No metastatic disease and/or nodal spread by CT scan or MRI
  • Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI
  • No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy

PATIENT CHARACTERISTICS:

  • Able to tolerate a transrectal ultrasound
  • Not allergic to latex
  • Fit for major surgery as assessed by a consultant anaesthetist
  • Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy
  • No androgen suppression and/or hormone treatment within the past 12 months
  • No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)
  • No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years
  • No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
Total proportion of men with erectile dysfunction and/or incontinence

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Investigators

  • Principal Investigator: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000652331
  • UCL-09-H0714-7
  • EU-20977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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