COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

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: NCT00030290
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: high-intensity focused ultrasound ablation Phase 1

Detailed Description:


  • Determine the ability of Sonablate to focus ultrasonic 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 organ-confined prostate cancer.

OUTLINE: This is a multicenter study.

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 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 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 will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
Study Start Date : October 2001
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed organ-confined prostate cancer (clinical stage T1 or T2 only)
  • Pretreatment prostate weight less than 40 g
  • Gleason score no greater than 7
  • PSA no greater than 10 ng/mL
  • No significant intravesical median lobe (greater than 2 cm) on ultrasound
  • Able to visualize prostate gland adequately 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 category IV or greater
  • No interest in future fertility
  • No history of inflammatory bowel disease
  • No other concurrent major 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


  • No prior radiotherapy for prostate cancer


  • No prior transurethral resection of prostate
  • No prior urethral stent
  • No prior major rectal surgery


  • No prior cryotherapy for prostate cancer
  • No prior thermotherapy
  • No other prior therapy for prostate cancer
  • No concurrent warfarin or other anticoagulant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030290

Layout table for location information
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Sponsors and Collaborators
Focus Surgery
Layout table for investigator information
Study Chair: Michael O. Koch, MD Indiana University Melvin and Bren Simon Cancer Center

Layout table for additonal information Identifier: NCT00030290    
Other Study ID Numbers: FOCUS-G000276
CDR0000069126 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2008
Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases