Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
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.
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.
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