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


Phase 1
40 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael O. Koch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

FOCUS-G000276

NCT ID:

NCT00030290

Start Date:

October 2001

Completion Date:

February 2006

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265