An interventional study of Biopsy of Prostate and Magnetic Resonance Imaging in Prostate Carcinoma, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Diagnostic
This clinical trial studies whether transperineal micro-ultrasound can be used to detect prostate cancer during biopsy. Transrectal ultrasound is often used during prostate biopsy. Transrectal ultrasound imaging is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Transrectal ultrasound is used to look for abnormalities in the rectum and nearby structures, including the prostate. The images are used to guide the prostate biopsy. Transperineal micro-ultrasound is completed by placing a probe over the skin between the scrotum and anus (perineum). It is a high-resolution ultrasound at 29 megahertz (MHz) (compared to traditional ultrasound at 6-9 MHz). This higher frequency allows for an improved spatial resolution. This improved spatial resolution is approximately the diameter of a prostatic duct, and therefore, may be able to visualize slight changes in the structure of prostatic ducts that are not possible with standard transrectal ultrasound. Transperineal micro-ultrasound may be more effective in detecting 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.
Exclusion Criteria:
Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo MRI during screening.
Procedure: Biopsy of Prostate · Procedure: Magnetic Resonance Imaging · Procedure: Micro-ultrasound Imaging
Undergo standard of care prostate biopsy
Also known as: Prostate Biopsy, Prostatic Biopsy
Undergo MRI
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 transperineal micro-ultrasound imaging
Also known as: Micro ultrasound, Micro ultrasound Imaging, Micro-ultrasound, microUS
Undergo transrectal micro-ultrasound imaging
Also known as: Micro ultrasound, Micro ultrasound Imaging, Micro-ultrasound, microUS
Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)
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.
Time frame: Up to 2 months
Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring
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.
Time frame: Up to 2 months
Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring
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.
Time frame: Up to 2 months
Successful generation of PRIMUS score in transperineal and transrectal ultrasound images
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.
Time frame: Up to 7 months
Ability to visualize the whole prostate using transperineal micro-ultrasound
This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.
Time frame: Up to 7 months
Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate
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.
Time frame: Up to 7 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Roswell Park Cancer Institute