Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

NCT ID: NCT00030290

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2006-02-28

Brief Summary

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.

Detailed Description

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.

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 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

• 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

Countries

United States

Other Identifiers

CDR0000069126

Identifier Type: REGISTRY

Identifier Source: secondary_id

CWRU-050130

Identifier Type: -

Identifier Source: secondary_id

IUMC-010233

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1684

Identifier Type: -

Identifier Source: secondary_id

FOCUS-G000276

Identifier Type: -

Identifier Source: org_study_id