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High-Intensity Focused Ultrasound Ablation 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.
 
ClinicalTrials.gov Identifier: NCT00561314
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 17, 2007
First Posted Date  ICMJE November 20, 2007
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE July 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2007)
  • Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
  • Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2007)
Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
Official Title  ICMJE An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
Brief Summary

RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.

PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.

Secondary

  • To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.

OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients are then evaluated over a 12-month period.

Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.

Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Sexual Dysfunction
  • Urinary Incontinence
Intervention  ICMJE
  • Other: questionnaire administration
  • Procedure: biopsy
  • Procedure: high-intensity focused ultrasound ablation
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Not Provided
Publications * Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 17, 2007)
33
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Low-risk disease, as defined by the following criteria:

      • Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
      • Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
      • Serum PSA ≤ 15 ng/mL
  • Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
  • Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
  • All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
  • No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 5 years
  • Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
  • No prior rectal fistula
  • No American Society of Anesthesiology grades III-IV
  • No latex allergies
  • No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
  • No moderate to severe inflammatory bowel disease

PRIOR CONCURRENT THERAPY:

  • No androgen suppression treatment within the past 6 months
  • No transurethral resection of the prostate or laser prostatectomy within the past 5 years
  • No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
  • No prior significant rectal surgery preventing insertion of transrectal probe
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00561314
Other Study ID Numbers  ICMJE CDR0000574344
UCLCTC-UCLH-FOCAL-HIFU
EU-20773
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University College London Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

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