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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biopsy of Prostate
  • Magnetic Resonance Imaging
  • Micro-ultrasound Imaging
  • Micro-ultrasound Imaging

Treatment groups

138 Participants
are divided into 1 treatment group

Locations

1
Roswell Park Cancer Institute14263, BuffaloNew York, United States

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor