Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02524860
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2015
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Focal Healthcare Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Focal-Fusion Bx Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound

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 Name: MRI-ultrasound fusion device

Primary Outcome Measures :
  1. Proportion of biopsy cores positive for clinically significant cancer. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of men diagnosed with clinically significant and clinically insignificant cancer. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02524860

United States, Florida
Urology Treatment Center (division of 21st Century Oncology, Inc.)
Sarasota, Florida, United States, 34239
Sponsors and Collaborators
Focal Healthcare Inc.
Principal Investigator: Winston Barzell, MD 21st Century Oncology, Inc.

Responsible Party: Focal Healthcare Inc. Identifier: NCT02524860     History of Changes
Other Study ID Numbers: 20150330, version 2.0
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Focal Healthcare Inc.:
Prostate Cancer
High Risk Cancer
Focal Healthcare
Fusion Targeted Biopsy
Multiparametric Magnetic Resonance Imaging (MP-MRI)
MRI-Ultrasound Fusion
Focal-Fusion Bx

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases