Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Asan Medical Center

Status: Unknown

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Urinary multimarker sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT04825002

2021-0305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Urinary multimarker sensor arm

Experimental group

Description:

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

Treatment:

Diagnostic Test: Urinary multimarker sensor