Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

NCT ID: NCT04825002

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2023-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Urinary multimarker sensor arm

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

Group Type: EXPERIMENTAL

Urinary multimarker sensor

Intervention Type: DIAGNOSTIC_TEST

We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.

Interventions

Urinary multimarker sensor

We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea

UNKNOWN

Sponsor Role: collaborator

Korea Medial Device Development Fund grant funded by the Korean government

UNKNOWN

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

In Gab Jeong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Choung-Soo Kim, MD

Role: CONTACT

cskim@amc.seoul.kr

82-2-3010-3734

Facility Contacts

In Gab Jeong, MD

Role: primary

igjeong@amc.seoul.kr

82-2-3010-5892

Bumjin Lim, MD

Role: backup

lbj1986@hanmail.net

82-2-3010-1835

Other Identifiers

2021-0305

Identifier Type: -

Identifier Source: org_study_id