Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy
ConditionProstate Carcinoma
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Biopsy of Prostate
Procedure/SurgeryUndergo standard of care prostate biopsy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Micro-ultrasound Imaging
Procedure/SurgeryUndergo transperineal micro-ultrasound imaging
Micro-ultrasound Imaging
Procedure/SurgeryUndergo transrectal micro-ultrasound imaging
Treatment groups
138 Participants
are divided into 1 treatment groupGroup A: Diagnostic (transperineal micro-ultrasound)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov