Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030290
First received: February 14, 2002
Last updated: July 9, 2013
Last verified: December 2008
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: high-intensity focused ultrasound ablation
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System

Resource links provided by NLM:


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

Study Start Date: October 2001
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 40 to 80

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No bleeding disorder as determined by abnormal PT and PTT

Renal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for prostate cancer

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

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

Radiotherapy:

  • No prior radiotherapy for prostate cancer

Surgery:

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

Other:

  • No prior cryotherapy for prostate cancer
  • No prior thermotherapy
  • No other prior therapy for prostate cancer
  • No concurrent warfarin or other anticoagulant
  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: NCT00030290

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Sponsors and Collaborators
Focus Surgery
Investigators
Study Chair: Michael O. Koch, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00030290     History of Changes
Other Study ID Numbers: FOCUS-G000276, CDR0000069126, CWRU-050130, IUMC-010233, NCI-V01-1684
Study First Received: February 14, 2002
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA 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 September 30, 2014