Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

Prostate Cancer Clinical Trial

Official title:

Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030290
• Other study ID #: FOCUS-G000276
• Secondary ID: CDR0000069126CWR
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2002
• Last updated: July 9, 2013
• Start date: October 2001
• Est. completion date: February 2006

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• high-intensity focused ultrasound ablation

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Focus Surgery

Country where clinical trial is conducted

United States,