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. 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
Information provided by:
National Cancer Institute (NCI)

September 30, 2009
October 1, 2009
August 26, 2013
July 2009
Not Provided
  • Total proportion of men with erectile dysfunction and/or incontinence
  • Quality of life
Same as current
Complete list of historical versions of study NCT00988130 on Archive Site
  • Success of index lesion ablation with HIFU at 6 months
  • Prostate-specific antigen kinetics
  • Proportion of men requiring androgen blockade at 12 months
Same as current
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High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
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.



  • 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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Not Provided
Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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  • 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


  • 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.)


  • 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
Sexes Eligible for Study: Male
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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University College London Hospitals
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Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
National Cancer Institute (NCI)
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP