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

September 30, 2009
August 23, 2013
July 2009
Not Provided
  • Total proportion of men with erectile dysfunction and/or incontinence [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988130 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
Not Provided
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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
Male
Not Provided
No
United Kingdom
 
NCT00988130
CDR0000652331, UCL-09-H0714-7, EU-20977
Not Provided
Not Provided
University College London Hospitals
Not Provided
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
National Cancer Institute (NCI)
May 2011

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