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Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
high-intensity focused ultrasound ablation
Sponsored by
Focus Surgery
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
July 9, 2013
Sponsor
Focus Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00030290
Brief Title
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
Official Title
Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Focus Surgery

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
high-intensity focused ultrasound ablation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O. Koch, MD
Organizational Affiliation
Indiana University Melvin and Bren Simon Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

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