High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized 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: NCT00561262
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

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

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Treatment
Official Title: An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
Study Start Date : May 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Feasibility
  2. Adverse events
  3. Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function
  4. Side effect profile

Secondary Outcome Measures :
  1. Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
  2. Exclusion of cancer on MRI at 2-7 days and at 6 months
  3. Transrectal ultrasound biopsies at 6 months
  4. Need for secondary or adjuvant treatment for prostate cancer following therapy

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:   up to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:

    • Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
    • Cancer prostate-confined only
    • Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy
    • Serum prostate-specific antigen (PSA) ≤ 15 ng/mL
    • Prostate volume ≤ 40 cc OR AP length of prostate < 4 cm
  • Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial
  • No evidence of metastatic disease
  • No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate


  • Life expectancy ≥ 5 years
  • No latex allergies
  • No American Society of Anesthesiology surgical risk score III or IV
  • No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images)
  • Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist


  • More than 6 months since prior androgen suppression therapy
  • No prior radiotherapy for prostate cancer
  • No prior chemotherapy for prostate cancer
  • No prior significant rectal surgery preventing insertion of transrectal probe
  • No prior transurethral resection of the prostate or laser prostatectomy
  • No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate

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): NCT00561262

United Kingdom
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
University College London Hospitals
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals

Publications of Results: Identifier: NCT00561262     History of Changes
Other Study ID Numbers: CDR0000574367
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
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