High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030277
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

February 14, 2002
January 27, 2003
July 10, 2013
October 2001
October 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00030277 on Archive Site
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High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System

RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.

PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer.


  • Determine the ability of Sonablate to focus ultrasound waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with locally recurrent prostate cancer.

OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs post-external beam radiotherapy).

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 with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.

Patients are followed at 2, 14, 30, 90, and 180 days.

PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study.

Phase 1
Primary Purpose: Treatment
Prostate Cancer
Procedure: high-intensity focused ultrasound ablation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2008
October 2007   (Final data collection date for primary outcome measure)


  • Histologically confirmed locally recurrent prostate cancer after prior brachytherapy or external-beam radiotherapy for initial diagnosis of organ-confined disease (clinical stage T1 or T2 only)

    • Prostatic fossa biopsy positive for cancer cells
  • Gleason score no greater than 7
  • PSA levels 0.5-10 ng/mL
  • Able to adequately visualize local recurrence on transrectal ultrasound imaging
  • No prostate calcification greater than 5 mm
  • No metastases by bone scan



  • 40 to 80

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • No bleeding disorder as determined by abnormal PT and PTT


  • No active urinary tract infection
  • No history of urinary bladder neck contracture


  • No prior allergy to latex
  • No Anesthesia Surgical Assignment (ASA) category IV or greater
  • No interest in future fertility
  • No history of inflammatory bowel disease
  • No other concurrent major nonmalignant debilitating illness
  • No other prior or concurrent malignancy except skin cancer


Biologic therapy:

  • No prior biologic therapy for prostate cancer


  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior radical prostatectomy
  • No prior transurethral resection of prostate
  • No prior urethral stent
  • No prior major rectal surgery


  • No prior thermotherapy
  • No other prior therapy for prostate cancer
  • No concurrent warfarin or other anticoagulant
Sexes Eligible for Study: Male
40 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000069125 ( Registry Identifier: PDQ (Physician Data Query) )
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Focus Surgery
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Study Chair: Michael O. Koch, MD Indiana University Melvin and Bren Simon Cancer Center
National Cancer Institute (NCI)
December 2008

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