Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

NCT02524860 | Unknown

• 1 other identifier: 20150330, version 2.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of biopsy cores positive for clinically significant cancer.

  12 months

Secondary Outcomes (1)

• Number of men diagnosed with clinically significant and clinically insignificant cancer.

  12 months

Study Arms (1)

MRI-ultrasound fusion device

EXPERIMENTAL

Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging

Device: Focal-Fusion Bx

Interventions

Focal-Fusion Bx DEVICE

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.

Also known as: MRI-ultrasound fusion device

MRI-ultrasound fusion device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Focal Healthcare Inc.: lead

Study Sites (1)

Urology Treatment Center (division of 21st Century Oncology, Inc.)

Sarasota, Florida, 34239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Winston Barzell, MD

  21st Century Oncology, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

US (1)