Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
40 Years
80 Years
Male
Prostate Cancer
Trial Information
Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
OBJECTIVES:
- 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.
Inclusion Criteria
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)
- 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
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 (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
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:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
- No prior radical prostatectomy
- No prior transurethral resection of prostate
- No prior urethral stent
- No prior major rectal surgery
Other:
- No prior thermotherapy
- No other prior therapy for prostate cancer
- No concurrent warfarin or other anticoagulant
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michael O. Koch, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Indiana University Melvin and Bren Simon Cancer Center
Authority:
United States: Federal Government
Study ID:
FOCUS-G000280
NCT ID:
NCT00030277
Start Date:
October 2001
Completion Date:
December 2008
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Long Island College Hospital | Brooklyn, New York 11201 |
