Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

March 29, 2021 updated by: In Gab Jeong, Asan Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Diagnostic test: Urinary multimarker sensor
We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence vs. absence of clinically significant prostate cancer on prostate biopsy
Time Frame: through study completion, an average of 3 year
(≥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
Time Frame: through study completion, an average of 3 year
presence or absence of prostate cancer at prostate biopsy
through study completion, an average of 3 year
Optimal cutoff points for the each biomarker
Time Frame: through study completion, an average of 3 year
cutoff points for each biomarker (ANXA3, PSMA, ERG, ENG)
through study completion, an average of 3 year
Accuracy of each biomarker
Time Frame: through study completion, an average of 3 year
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
Time Frame: through study completion, an average of 3 year
Area Under Curve for each biomarker alone or combination
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea
Korea Medial Device Development Fund grant funded by the Korean government

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 22, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 20, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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