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

Purpose

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.

Condition

  • Prostate Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diagnostic (transperineal micro-ultrasound) 		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
    Undergo standard of care prostate biopsy
    Other names:
    • Prostate Biopsy
    • Prostatic Biopsy
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • 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
  • Procedure: Micro-ultrasound Imaging
    Undergo transperineal micro-ultrasound imaging
    Other names:
    • Micro ultrasound
    • Micro ultrasound Imaging
    • Micro-ultrasound
    • microUS
  • Procedure: Micro-ultrasound Imaging
    Undergo transrectal micro-ultrasound imaging
    Other names:
    • Micro ultrasound
    • Micro ultrasound Imaging
    • Micro-ultrasound
    • microUS

Recruiting Locations

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Khurshid A. Guru
716-845-6844
Khurshid.guru@roswellpark.org

More Details

Status
Recruiting
Sponsor
Roswell Park Cancer Institute

Study Contact

Detailed Description

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.