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

NCT ID: NCT00030277

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

high-intensity focused ultrasound ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Focus Surgery

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael O. Koch, MD

Role: STUDY_CHAIR

Indiana University Melvin and Bren Simon Cancer Center

Locations

Indiana University Cancer Center

Indianapolis, Indiana, United States

Long Island College Hospital

Brooklyn, New York, United States

Countries

United States

Other Identifiers

CDR0000069125

Identifier Type: REGISTRY

Identifier Source: secondary_id

IUMC-010235

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1683

Identifier Type: -

Identifier Source: secondary_id

FOCUS-G000280

Identifier Type: -

Identifier Source: org_study_id