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Status unknownNCT04825002Updated Apr 1, 2021

Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

An interventional study of Urinary multimarker sensor in Prostate Cancer, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
Male
01

Study 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.

Read the 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.
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Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
  • biopsy
  • urine
  • biomarker
  • nanoparticle
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 800 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
800 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testUrinary multimarker sensor

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

06

What researchers measure

Primary outcomes

  1. Presence vs. absence of clinically significant prostate cancer on prostate biopsy

    (≥Gleason score 3+4)

    Time frame: through study completion, an average of 3 year

Secondary outcomes

  1. Presence vs. absence of overall prostate cancer

    presence or absence of prostate cancer at prostate biopsy

    Time frame: through study completion, an average of 3 year

  2. Optimal cutoff points for the each biomarker

    cutoff points for each biomarker (ANXA3, PSMA, ERG, ENG)

    Time frame: through study completion, an average of 3 year

  3. Accuracy of each biomarker

    sensitivity, specificity, positive/negative predictive value

    Time frame: through study completion, an average of 3 year

  4. Area Under Curve (Receiver operating curve) by multivariable linear regression model

    Area Under Curve for each biomarker alone or combination

    Time frame: through study completion, an average of 3 year

07

Study locations

1 of 1 sites recruiting
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04825002
Lead 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
Responsible party
In Gab Jeong (Professor, Asan Medical Center) — Principal investigator
First posted
Apr 1, 2021
Start date
Mar 22, 2021 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 1, 2021

Study contacts

Choung-Soo Kim, MD
Contact
cskim@amc.seoul.kr
82-2-3010-3734

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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