Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Not Applicable

Brief Summary: This trial aims to develop and validate the urinary multimarker sensor which can measure trace amounts of biomarkers from naturally voided urine in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that urinary multimarker sensor will help to avoid unnecessary prostate biopsy while detect the clinically significant cancers.

Detailed Description: The investigators will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.

1. Urine specimen collection. This study was approved by the Institutional Review Board of the Asan Medical Center (Seoul, Republic of Korea) and informed consent will be obtained from all subjects. Biomarkers diffused passively from prostate tissue to the urethra and will be collected from naturally voided urine. Urine will be collected in a sterilized specimen cup containing 10 vol% RNA stabilizer and 1vol% antibiotics and stored in a refrigerator for less than a week before shipping the sample to the laboratory

2. To measure the electrical signals from the four different biomarkers in the urine, the four sensing channels in the extended gate of an field-effect transistor biosensor will be conjugated to antibodies, thus capturing different biomarkers.

3. Without any pretreatment, urine will be added directly to the four different sensing channels. After 20 min of reaction time in the four channels, the bottom gate voltage shifts will be measured at the reference current (1 nA). Each urine sample will generate four independent sensing signals from the corresponding biomarkers. The set of sensing signals collected for each patient will be then analyzed.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients has any prior needle biopsy of the prostate
Patients has a prior history of prostate cancer
Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
Patients has a prior history of BPH operation
Patient with uncorrectable coagulopathies
Unable to tolerate a TRUS guided biopsy.
Patients had 5-alpha reductase inhibitor in the past six months.
The patient has had a urinary tract infection or acute prostatitis in the last three months.

Arm && Interventions

Group	Intervention	Description
Urinary multimarker sensor arm	Urinary multimarker sensor	A urine of this group will be collected and measured using a newly developed urinary multimarker sensor (ANXA3, PSMA, ERG, ENG)

Primary Outcome Measures

Name	Time	Method
Presence vs. absence of clinically significant prostate cancer on prostate biopsy	through study completion, an average of 3 year	(≥Gleason score 3+4)

Secondary Outcome Measures

Name	Time	Method
Accuracy of each biomarker	through study completion, an average of 3 year	sensitivity, specificity, positive/negative predictive value
Presence vs. absence of overall prostate cancer	through study completion, an average of 3 year	presence or absence of prostate cancer at prostate biopsy
Optimal cutoff points for the each biomarker	through study completion, an average of 3 year	cutoff points for each biomarker (ANXA3, PSMA, ERG, ENG)
Area Under Curve (Receiver operating curve) by multivariable linear regression model	through study completion, an average of 3 year	Area Under Curve for each biomarker alone or combination

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