Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Roswell Park Cancer Institute
PRIMARY OBJECTIVES:
I. To investigate the feasibility and validity of using transperineal micro-ultrasound to image the prostate and detect clinically significant prostate cancer.
II. To test the quality of visualization of the prostate gland using micro-ultrasound via the transperineal approach.
SECONDARY OBJECTIVE:
I. To compare micro-ultrasound images done via the transperineal method to micro-ultrasound images done via the transrectal method to see if transperineal ultrasound has similar ability to detect suspicious prostate lesions as transrectal micro-ultrasound.
OUTLINE:
Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo magnetic resonance imaging (MRI) during screening.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Men aged ≥ 18 years
Men scheduled for transrectal ultrasound guided prostate biopsy who have had a prebiopsy MRI. Therefore patients unable to have a prebiopsy MRI who have contraindications to MRI or unwilling to undergo MRI would be excluded
The participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form before receiving any study-related procedure
You may not be if
Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation
Clareo Health | Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy
