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Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

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ClinicalTrials.gov Identifier: NCT04825002
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
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
Information provided by (Responsible Party):
In Gab Jeong, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: Urinary multimarker sensor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
Estimated Study Start Date : March 22, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Accuracy of each biomarker [ Time Frame: through study completion, an average of 3 year ]
    sensitivity, specificity, positive/negative predictive value

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825002


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

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: In Gab Jeong, MD    82-2-3010-5892    igjeong@amc.seoul.kr   
Contact: Bumjin Lim, MD    82-2-3010-1835    lbj1986@hanmail.net   
Principal Investigator: In Gab Jeong, MD,PhD         
Sponsors and Collaborators
Asan Medical Center
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
More Information
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Responsible Party: In Gab Jeong, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04825002    
Other Study ID Numbers: 2021-0305
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by In Gab Jeong, Asan Medical Center:
prostate cancer
biopsy
urine
biomarker
nanoparticle
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases