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

Tracking Information

First Received Date ^ICMJE

October 14, 2008

Last Updated Date

November 24, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00772317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Locally Recurrent Prostate Cancer With HIFU

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Recurrent Prostate Cancer

Intervention ^ICMJE

Device: High Intensity Focused Ultrasound

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

202

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00772317

Responsible Party

Andrew Green, Vice President of Scientific Affairs, USHIFU

Study ID Numbers ^ICMJE

FSI-003

Study Sponsor ^ICMJE

USHIFU, LLC

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Herbert Lepor, MD

NYU

Information Provided By

USHIFU, LLC

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP