High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
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.
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.
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