Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524860

Enrollment

Registered

2015-08-17

Start date

2015-09-30

Completion date

2017-09-30

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Biopsy, Focal Healthcare, Fusion Targeted Biopsy, High Risk Cancer, Imaging, Diagnostic, Ultrasound, Multiparametric Magnetic Resonance Imaging (MP-MRI), MRI-Ultrasound Fusion, Focal-Fusion Bx

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.

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.

Interventions

DEVICEFocal-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of biopsy cores positive for clinically significant cancer.	12 months

Secondary

Measure	Time frame
Number of men diagnosed with clinically significant and clinically insignificant cancer.	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026