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
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 33
Study Start Date: July 2007
Study Completion Date: January 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561314

Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00561314     History of Changes
Other Study ID Numbers: CDR0000574344, UCLCTC-UCLH-FOCAL-HIFU, EU-20773
Study First Received: November 17, 2007
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
urinary incontinence
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Urinary Incontinence
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014