A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU - Full Text View

A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU (SetPace)

This study is currently recruiting participants.

Verified by USHIFU, LLC, September 2009

First Received: October 9, 2008 Last Updated: September 28, 2009 History of Changes

Sponsor:	USHIFU, LLC
Information provided by:	USHIFU, LLC
ClinicalTrials.gov Identifier:	NCT00770822

Purpose

This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Device: HIFU (Sonablate® 500) Device: Brachytherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by USHIFU, LLC:

Primary Outcome Measures:

The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	466
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Device, HIFU: Experimental High Intensity Focused Ultrasound	Device: HIFU (Sonablate® 500) High Intensity Focused Ultrasound
Device, brachytherapy: Active Comparator Brachytherapy	Device: Brachytherapy Standard of care

Detailed Description:

The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the SB-500 device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the SB-500 arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the SB-500 arm.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

T1c or T2a carcinoma of the prostate;
Gleason score ≤6;
serum prostate specific antigen(PSA) ≤10 ng/ml;
prostate volume <40 cc;

Exclusion Criteria:

men who have had previous definitive treatment for prostate cancer
prior hormonal therapy for prostate cancer (including bilateral orchiectomy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770822

Contacts

Contact: Andrew Green	980-322-2090	drewgreen@ushifu.com
Contact: Dawn Rice, RN, MBA, CCRA	678-896-1575	dawnrice@ushifu.com

Locations

United States, Alabama
Urology Centers of Alabama	Recruiting
Birmingham, Alabama, United States
United States, Florida
Specialists in Urology	Recruiting
Naples, Florida, United States
United States, South Carolina
Grand Strand Urology	Recruiting
Myrtle Beach, South Carolina, United States
United States, Tennessee
Urology Associates	Active, not recruiting
Nashville, Tennessee, United States
Southeast Urology Network	Active, not recruiting
Memphis, Tennessee, United States
United States, Texas
Urology of San Antonio	Active, not recruiting
San Antonio, Texas, United States
United States, Wisconsin
Univ of Wisconsin Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States

Sponsors and Collaborators

USHIFU, LLC

More Information

No publications provided

Responsible Party:	USHIFU ( Andrew Green, VP of Scientific Affairs )
Study ID Numbers:	FSI-002
Study First Received:	October 9, 2008
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00770822 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by USHIFU, LLC:

Primary
Prostate
Cancer
Primary T1c/T2a organ confined prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009