Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
40 Years
80 Years
Male
Prostate Cancer
Trial Information
Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
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.
Inclusion 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
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-G000276
NCT ID:
NCT00030290
Start Date:
October 2001
Completion Date:
February 2006
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
