Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

July 9, 2013 updated by: Focus Surgery

Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Focus Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOCUS-G000276
  • CDR0000069126 (Registry Identifier: PDQ (Physician Data Query))
  • CWRU-050130
  • IUMC-010233
  • NCI-V01-1684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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