High-Intensity Focused Ultrasound 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. Identifier: NCT00987675
Recruitment Status : Unknown
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 1, 2009
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: pharmacological study Other: questionnaire administration Procedure: assessment of therapy complications Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Primary Purpose: Treatment
Official Title: An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Success of treatment as demonstrated by the absence of cancer at 6 months
  2. PSA kinetics after completion of treatment
  3. Proportion of patients requiring androgen blockade at 12 months

Information from the National Library of Medicine

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


  • Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:

    • Stage ≤ T3b, N0, M0 disease
    • Gleason score ≤ 8
    • Serum PSA ≤ 20 ng/mL
    • No metastatic disease and nodal spread by staging CT or MRI

      • Negative bone scan within the past 6 months
  • Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI

    • Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved


  • Able to tolerate a transrectal ultrasound
  • Able to undergo major surgery as assessed by a consultant anesthesiologist
  • Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
  • No urethral stricture or presence of metal implants or stents in the urethra
  • No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
  • No allergy to latex


  • No prior radiotherapy
  • No prior treatment with any of the following:

    • Transurethral resection of the prostate or equivalent procedures within the past 2 years
    • High-intensity focused ultrasound ablation (HIFU)
    • Cryosurgery
    • Thermal or microwave therapy to the prostate
  • No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
  • More than 12 months since prior androgen suppression or hormone treatment for prostate cancer

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 identifier (NCT number): NCT00987675

United Kingdom
University College Hospital Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Hashim Uddinn Ahmed, MD    44-20-7380-9194      
Sponsors and Collaborators
University College London Hospitals
OverallOfficial: Hashim Uddinn Ahmed, MD University College London Hospitals Identifier: NCT00987675     History of Changes
Other Study ID Numbers: CDR0000650138
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: March 2011

Keywords provided by National Cancer Institute (NCI):
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
Genital Diseases, Male
Prostatic Diseases