Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	40 to 80	Other	FOCUS-G000280 IUMC-010235, NCI-V01-1683, NCT00030277

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

A total of 20 patients (10 per stratum) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Focus Surgery, Incorporated

Michael O. Koch, MD, Protocol chair		Ph: 317-278-4822; 888-600-4822

Registry Information
Official Title		Feasibility Study for Locally Recurrent Prostate Cancer Treatment with HIFU Using the SONABLATE System
Trial Start Date		2001-10-26
Trial Completion Date		2007-10-09
Registered in ClinicalTrials.gov		NCT00030277
Date Submitted to PDQ		2001-10-26
Information Last Verified		2008-12-08

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