A Multicenter Clinical Study of the Sonablate®500 for the Treatment of Locally Recurrent Prostate Cancer With HIFU - Full Text View

Sponsor:	USHIFU, LLC
Information provided by:	USHIFU, LLC
ClinicalTrials.gov Identifier:	NCT00772317

Purpose

For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT) with or without High Dose Rate Brachytherapy.

Condition	Intervention	Phase
Recurrent Prostate Cancer	Device: High Intensity Focused Ultrasound	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Locally Recurrent Prostate Cancer With HIFU

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by USHIFU, LLC:

Primary Outcome Measures:

achieving a PSA nadir of ≤ 0.5 ng/mL within 12 months of treatment [ Time Frame: 12 months post treatment ] [ Designated as safety issue: Yes ]
negative prostate biopsy at the 12 month time point [ Time Frame: 12 months post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	202
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HIFU: Experimental	Device: High Intensity Focused Ultrasound High Intensity Focused Ultrasound

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with initial presentation of organ confined recurrent prostate cancer (clinical stages T1c and T2a only) who have been treated with EBRT (conventional, 3D conformal, or IMRT) with or without High Dose Rate (HDR) Brachytherapy two or more years prior, and currently have biopsy proven local recurrence. Previous radiation therapy must be a documented therapeutic dose of 60 to 78 Gy (inclusive);
Negative bone scan within 3 months prior to enrollment to rule out possibility of metastases;
Negative CT scans of the chest, abdomen, and pelvis within 3 months prior to enrollment to rule out possibility of metastases
Gleason score ≤ 7;
Serum prostate specific antigen (PSA) ≥ 0.5 ng/mL and ≤ 10 ng/mL;

Exclusion Criteria:

ASA of IV or higher
Large calcifications (> 1 cm) in the area to be treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772317

Contacts

Contact: Dawn Rice, RN, MBA, CCRA

678-896-1575

dawnrice@ushifu.com

Locations

United States, Alabama
Urology Centers of Alabama, PC	Recruiting
Birmingham, Alabama, United States, 35209
Principal Investigator: Lee Hammontree, M.D.
United States, California
David Geffen School of Medicine at University of California Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Leonard Marks, M.D.
Principal Investigator: Allan Pantuck, M.D.
United States, District of Columbia
Walter Reed Army Medical Center	Recruiting
Washington, District of Columbia, United States, 20307
Principal Investigator: COL. David G. McLeod, M.C., M.D.
United States, Florida
Specialists in Urology, P.A.	Recruiting
Naples, Florida, United States, 34102
Principal Investigator: Nicholas Franco, M.D.
United States, Indiana
Metropolitan Urology, PSC	Recruiting
Jeffersonville, Indiana, United States, 47130
Principal Investigator: John Bailen, M.D.
United States, Iowa
Iowa Clinic	Recruiting
Des Moines, Iowa, United States, 50266
Principal Investigator: Jonathan M. Fialkov, M.D
United States, New York
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Principal Investigator: William Huang, M.D.
United States, Ohio
University Hospitals of Cleveland Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Lee Ponsky, M.D.
United States, Pennsylvania
Urologic Consultants of SE PA, LLP	Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Principal Investigator: Laurence H. Belkoff, D.O., M.D.
United States, South Carolina
Carolina Urologic Research Center, LLC	Recruiting
Myrtle Beach, South Carolina, United States, 29572
Principal Investigator: Neal Shore, M.D.
United States, Tennessee
Urology Associates, P.C.	Recruiting
Nashville, Tennessee, United States, 37209
Principal Investigator: Robert B. Barnett, M.D.
United States, Texas
University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: John Ward, M.D.
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: David F. Jarrard, M.D.
Canada, Ontario
London Health Sciences Center	Recruiting
London, Ontario, Canada, N6A 4G5
Principal Investigator: Joseph Chin, M.D.
CAN-AM	Recruiting
Toronto, Ontario, Canada, M6A 3B5
Principal Investigator: Jack Barkin, M.D.

Sponsors and Collaborators

USHIFU, LLC

Investigators

Study Director:

Herbert Lepor, MD

NYU

More Information

Additional Information:

Information for study participants This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	USHIFU ( Andrew Green, Vice President of Scientific Affairs )
Study ID Numbers:	FSI-003
Study First Received:	October 14, 2008
Last Updated:	December 4, 2009
ClinicalTrials.gov Identifier:	NCT00772317 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by USHIFU, LLC:

Recurrent
prostate cancer
ebrt
hifu

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site
Prostatic Diseases

Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

ClinicalTrials.gov processed this record on February 08, 2010