Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy

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.

• Biopsy of Prostate (Procedure), also known as Prostate Biopsy, Prostatic Biopsy: Undergo standard of care prostate biopsy
• Magnetic Resonance Imaging (Procedure), also known as Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI: Undergo MRI
• Micro-ultrasound Imaging (Procedure), also known as Micro ultrasound, Micro ultrasound Imaging, Micro-ultrasound, microUS: Undergo transperineal micro-ultrasound imaging
• Micro-ultrasound Imaging (Procedure), also known as Micro ultrasound, Micro ultrasound Imaging, Micro-ultrasound, microUS: Undergo transrectal micro-ultrasound imaging

Primary outcomes

• Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility) [Up to 2 months]: At the first stage, 28 patients will be enrolled. If the procedure was successful in at least 18 patients, the procedure will be considered feasible, and the study will proceed to the next stage. If less than 18 successes were observed, the study team will determine whether to continue the trial based on the data collected.
• Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring [Up to 2 months]: Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from base to apex with adequate image quality for PRIMUS scoring.
• Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring [Up to 2 months]: Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring.

Secondary outcomes

• Successful generation of PRIMUS score in transperineal and transrectal ultrasound images [Up to 7 months]: Will compare transrectal and transperineal micro-ultrasound assessment of PRIMUS score. This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.
• Ability to visualize the whole prostate using transperineal micro-ultrasound [Up to 7 months]: This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.
• Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate [Up to 7 months]: The quality of images of transperineal ultrasound will be compared to transrectal ultrasound of the prostate. Summary statistics in frequencies and relative frequencies will be provided.

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation

• Khurshid A Guru, Principal investigator, Roswell Park Cancer Institute