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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00987675
First received: September 30, 2009
Last updated: August 23, 2013
Last verified: March 2011
  Purpose

RATIONALE: High-intensity focused ultrasound 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 ablation and to see how well it works in treating patients with progressive prostate cancer.


Condition Intervention Phase
Prostate Cancer
Other: pharmacological study
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: high-intensity focused ultrasound ablation
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success of treatment as demonstrated by the absence of cancer at 6 months [ Designated as safety issue: No ]
  • PSA kinetics after completion of treatment [ Designated as safety issue: No ]
  • Proportion of patients requiring androgen blockade at 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: July 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.

Secondary

  • To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.
  • To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.
  • To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.

OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.

Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.

After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:

    • Stage ≤ T3b, N0, M0 disease
    • Gleason score ≤ 8
    • Serum PSA ≤ 20 ng/mL
    • No metastatic disease and nodal spread by staging CT or MRI

      • Negative bone scan within the past 6 months
  • Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI

    • Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved

PATIENT CHARACTERISTICS:

  • Able to tolerate a transrectal ultrasound
  • Able to undergo major surgery as assessed by a consultant anesthesiologist
  • Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
  • No urethral stricture or presence of metal implants or stents in the urethra
  • No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
  • No allergy to latex

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy
  • No prior treatment with any of the following:

    • Transurethral resection of the prostate or equivalent procedures within the past 2 years
    • High-intensity focused ultrasound ablation (HIFU)
    • Cryosurgery
    • Thermal or microwave therapy to the prostate
  • No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
  • More than 12 months since prior androgen suppression or hormone treatment for prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987675

Locations
United Kingdom
University College Hospital Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Hashim Uddinn Ahmed, MD    44-20-7380-9194      
Sponsors and Collaborators
University College London Hospitals
Investigators
Investigator: Hashim Uddinn Ahmed, MD University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00987675     History of Changes
Other Study ID Numbers: CDR0000650138, UCLH-09-H0714-7
Study First Received: September 30, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014