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

Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a detailed ultrasound scan can help find prostate cancer during a biopsy, when small tissue samples are taken. The scan uses a probe placed on the skin between the scrotum and anus. It is for men age 18 or older who have had an MRI scan and are scheduled for a prostate biopsy guided by ultrasound through the rectum.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older.
  • Scheduled for a prostate biopsy guided by ultrasound through the rectum.
  • Have had an MRI scan before the biopsy.
  • You or your legal representative must understand that this is a research study and sign a consent form before any study procedures.

Who can't join

  • Unable or unwilling to have an MRI scan before the biopsy, including for safety reasons.
  • Any condition that the study doctor believes makes you unsuitable for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY