Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

Status unconfirmed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02524860

Run by

Focal Healthcare Inc.

People needed

30

Starts

2015-09-01

Expected to finish

2017-09-01

Last updated by the study team

2017-03-16

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.