Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body
 temperature. This treatment may be effective for prostate cancer.

 PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating
 patients who have stage I or stage II prostate cancer that has recurred following radiation
 therapy.
OBJECTIVES: I. Determine the effectiveness of the Ablatherm high-intensity focused ultrasound
 device in providing control of disease for at least 12 months after treatment in patients
 with stage I or II prostate cancer recurring after external beam radiotherapy. II. Determine
 the safety of this treatment device in these patients.

 OUTLINE: This is an open-label, multicenter study. A probe is inserted into the rectum.
 Ultrasound energy is then delivered through probe to prostate tissue over 2-3 hours. Quality
 of life is assessed at study initiation; at 14 days and 3, 6, and 12 months; and then
 annually thereafter. Patients are followed at 14 days; at 3, 6, 9, and 12 months; and then
 annually thereafter.

 PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven stage I or II prostate cancer Organ confined
 (T1 or T2) At least 1 current positive biopsy Failed prior external beam radiotherapy for
 T1-T2 prostate cancer within last 18 months (with no worsening of the cancer in the first
 12 months after radiotherapy) PSA nadir less than 4 ng/mL after external beam radiotherapy
 If prior hormonal therapy, PSA must be greater than 1.0 ng/mL and testosterone level normal
 after therapy Prostate volume no greater than 35 g, or 35-50 g if maximum anterior
 posterior diameter no greater than 2.5 cm Kattan Nomogram at least .50 60-month
 recurrence-free probability prior to external beam radiotherapy ASA Classification 1-3 No
 lymph node involvement by CT scan No metastases No prostate seroma, prostate abscess, or
 active prostatitis Must meet the following conditions: No artificial sphincter, penile
 prosthesis, or intraprostatic implant such as stent or catheter Normal rectal anatomy and
 rectal mucosa Rectal wall measurement no greater than 6 mm with treatment probe in place No
 calcification inducing a shadow in the prostate that would preclude study No significant
 rectal or bladder morbidity after radiotherapy (RTOG/EORTC rectal or bladder scores at
 least 2) No rectal fibrosis, stenosis, fistula, disease, or other rectal anomalies that
 would make rectal probe insertion difficult

 PATIENT CHARACTERISTICS: Age: 50 and over Performance status: Not specified Life
 expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal:
 Creatinine greater than 1.8 mg/dL No prior superficial bladder cancer, urethral stricture,
 or bladder neck contracture No active urinary tract infection No upper urinary tract
 disease No compromised renal function No urinary tract fistula No urethral stenosis Other:
 No inflammatory bowel disease No interest in future fertility No prior HIV infection, AIDS,
 or other immunosuppression No known latex hypersensitivity Mentally coherent and capable of
 completing symptom and quality of life questionnaires No prior or concurrent illness or
 surgery that would preclude study or follow-up

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
 Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal
 therapy Radiotherapy: See Disease Characteristics No more than 10 permanent radioactive
 seed implants Less than 1 cm from prostate apex or less than 1.2 cm from rectal wall
 Surgery: At least 6 weeks since prior transurethral resection of the prostate or other
 prostate surgery No prior rectal surgery except hemorrhoidectomy Other: No definitive local
 treatment for prostate cancer since completion of external beam radiotherapy At least 2
 months since prior finasteride or other agents that affect PSA (e.g., saw palmetto) At
 least 3 months since prior benign prostatic hypertrophy thermotherapy or hyperthermia
 treatment At least 30 days since prior investigational drug or device No concurrent
 participation in another clinical trial