Clinical trial NCT02524860: Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
Official title: Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Focal Healthcare Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of biopsy cores positive for clinically significant cancer.
timeFrame: 12 months
Secondary outcomes:
measure: Number of men diagnosed with clinically significant and clinically insignificant cancer.
timeFrame: 12 months
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Urology Treatment Center (division of 21st Century Oncology, Inc.)
state: Florida
Study officials:
affiliation: 21st Century Oncology, Inc.
name: Winston Barzell, MD
role: PRINCIPAL_INVESTIGATOR
References: