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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00561314
First received: November 17, 2007
Last updated: August 23, 2013
Last verified: July 2009

November 17, 2007
August 23, 2013
July 2007
February 2009   (final data collection date for primary outcome measure)
  • Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events [ Designated as safety issue: Yes ]
  • 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 ... [ Designated as safety issue: No ]
  • 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 ...
Complete list of historical versions of study NCT00561314 on ClinicalTrials.gov Archive Site
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 ... [ Designated as safety issue: No ]
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 ...
Not Provided
Not Provided
 
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Prostate Cancer
  • Sexual Dysfunction
  • Urinary Incontinence
  • Other: questionnaire administration
  • Procedure: biopsy
  • Procedure: high-intensity focused ultrasound ablation
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
Not Provided
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.
 
Completed
33
January 2012
February 2009   (final data collection date for primary outcome measure)

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
Male
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00561314
CDR0000574344, UCLCTC-UCLH-FOCAL-HIFU, EU-20773
Not Provided
Not Provided
University College London Hospitals
Not Provided
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
National Cancer Institute (NCI)
July 2009

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