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| Sponsor: | Focus Surgery |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030277 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: high-intensity focused ultrasound ablation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2001 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, New York | |
| Long Island College Hospital | |
| Brooklyn, New York, United States, 11201 | |
| Study Chair: | Michael O. Koch, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00030277 History of Changes |
| Other Study ID Numbers: | CDR0000069125, FOCUS-G000280, IUMC-010235, NCI-V01-1683 |
| Study First Received: | February 14, 2002 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |