Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

March 14, 2017 updated by: Focal Healthcare Inc.

Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI

The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.

A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.

Three prostate sampling methods will be conducted in the same session on all patients. These include:

i) Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).

Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Urology Treatment Center (division of 21st Century Oncology, Inc.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Adult male subjects up to 80 years of age
  • Candidates for fusion biopsy
  • Elevated PSA levels
  • MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)
  • Subject is willing and able to read, understand and sign the Informed Consent Form document

Exclusion Criteria:

  • Previous treatment for prostate cancer
  • Any contraindication to a standard TRUS prostate biopsy procedure
  • Refusal to sign the Informed Consent document

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI-ultrasound fusion device
Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging
Device: Focal-Fusion Bx
The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.
Other Names:
  • MRI-ultrasound fusion device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of biopsy cores positive for clinically significant cancer.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of men diagnosed with clinically significant and clinically insignificant cancer.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Focal Healthcare Inc.

Investigators

  • Principal Investigator: Winston Barzell, MD, 21st Century Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150330, version 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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