High-Intensity Focused Ultrasound Focal 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 May 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00988130
First received: September 30, 2009
Last updated: August 23, 2013
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Total proportion of men with erectile dysfunction and/or incontinence [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success of index lesion ablation with HIFU at 6 months [ Designated as safety issue: No ]
  • Prostate-specific antigen kinetics [ Designated as safety issue: No ]
  • Proportion of men requiring androgen blockade at 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: July 2009
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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.)

PRIOR CONCURRENT THERAPY:

  • 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
  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: NCT00988130

Locations
United Kingdom
University College Hospital - London Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Mark Emberton, MD, FRCS, MBBS    44-20-7380-9194      
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00988130     History of Changes
Other Study ID Numbers: CDR0000652331, UCL-09-H0714-7, EU-20977
Study First Received: September 30, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Sexual Dysfunctions, Psychological
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014