Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Study Overview
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Brief Summary
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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
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The investigators will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine. 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 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. 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.

Official Title
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Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Urinary multimarker sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men undergoing a first-time prostate biopsy to rule out cancer Serum PSA ≥3ng/mL, ≤20ng/mL Age≥50 years, ≤80 years Clinical stage ≤T2c Patients must be able to provide written informed consent. 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinary multimarker sensor arm<br>A urine of this group will be collected and measured using a newly developed urinary multimarker sensor (ANXA3, PSMA, ERG, ENG) | Diagnostic Test: Urinary multimarker sensor<br>* We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence vs. absence of clinically significant prostate cancer on prostate biopsy | (≥Gleason score 3+4) | through study completion, an average of 3 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, prostate cancer, urine, biomarker, nanoparticle