We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00988130
Recruitment Status : Unknown
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 1, 2009
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Sexual Dysfunction Other: laboratory biomarker analysis Other: questionnaire administration Procedure: assessment of therapy complications Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
Study Start Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Total proportion of men with erectile dysfunction and/or incontinence
  2. Quality of life

Secondary Outcome Measures :
  1. Success of index lesion ablation with HIFU at 6 months
  2. Prostate-specific antigen kinetics
  3. Proportion of men requiring androgen blockade at 12 months

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988130


Locations
United Kingdom
University College Hospital - London Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Mark Emberton, MD, FRCS, MBBS    44-20-7380-9194      
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00988130     History of Changes
Other Study ID Numbers: CDR0000652331
UCL-09-H0714-7
EU-20977
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: May 2011

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases