Prostate CancerNCT04825002
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
A study testing Urinary multimarker sensor in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Urinary multimarker sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men undergoing a first-time prostate biopsy to rule out cancer
- Serum PSA ≥3ng/mL, ≤20ng/mL
- Age≥50 years, ≤80 years
- Clinical stage ≤T2c
- Patients must be able to provide written informed consent.
Who cannot join
- Patients has any prior needle biopsy of the prostate
- Patients has a prior history of prostate cancer
- Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- Patients has a prior history of BPH operation
- Patient with uncorrectable coagulopathies
- Unable to tolerate a TRUS guided biopsy.
- Patients had 5-alpha reductase inhibitor in the past six months.
- The patient has had a urinary tract infection or acute prostatitis in the last three months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
In Gab Jeong, MD, 82-2-3010-5892, igjeong@amc.seoul.kr
Bumjin Lim, MD, 82-2-3010-1835, lbj1986@hanmail.net
About this study
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.
- 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
- 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.
- 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
- Being tested
- Urinary multimarker sensor
- Keywords
- prostate cancer, biopsy, urine, biomarker, nanoparticle
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary multimarker sensorDiagnostic test
We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.
| Study group | Role | What they receive |
|---|---|---|
| Urinary multimarker sensor arm | Experimental | A urine of this group will be collected and measured using a newly developed urinary multimarker sensor (ANXA3, PSMA, ERG, ENG) Receives: Diagnostic Test: Urinary multimarker sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence vs. absence of clinically significant prostate cancer on prostate biopsy
(≥Gleason score 3+4)
Measured: through study completion, an average of 3 year
Secondary outcomes (4)
Presence vs. absence of overall prostate cancer
presence or absence of prostate cancer at prostate biopsy
Measured: through study completion, an average of 3 year
Optimal cutoff points for the each biomarker
cutoff points for each biomarker (ANXA3, PSMA, ERG, ENG)
Measured: through study completion, an average of 3 year
Accuracy of each biomarker
sensitivity, specificity, positive/negative predictive value
Measured: through study completion, an average of 3 year
Area Under Curve (Receiver operating curve) by multivariable linear regression model
Area Under Curve for each biomarker alone or combination
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea, Korea Medical Device Development Fund
- Responsible party
- Principal investigator, In Gab Jeong, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825002
- Sponsor's protocol ID
- 2021-0305
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
- ClinicalTrials.gov ID
- NCT04825002
- Acronym / sponsor ID
- 2021-0305
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, biopsy, urine, biomarker, nanoparticle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea, Korea Medical Device Development Fund
- Study start
- 22 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary multimarker sensor arm | Experimental | Diagnostic Test: Urinary multimarker sensorA urine of this group will be collected and measured using a newly developed urinary multimarker sensor (ANXA3, PSMA, ERG, ENG) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men undergoing a first-time prostate biopsy to rule out cancer
- Serum PSA ≥3ng/mL, ≤20ng/mL
- Age≥50 years, ≤80 years
- Clinical stage ≤T2c
- Patients must be able to provide written informed consent.
Key exclusion criteria (8 listed)
- Patients has any prior needle biopsy of the prostate
- Patients has a prior history of prostate cancer
- Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- Patients has a prior history of BPH operation
- Patient with uncorrectable coagulopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary multimarker sensorWe will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine. | Diagnostic test | Urinary multimarker sensor arm |
Primary outcome
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)
4 secondary outcomes
Presence vs. absence of overall prostate cancer
Time frame: 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
Accuracy of each biomarker
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary multimarker sensor in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choung-Soo Kim, MD (82-2-3010-3734, cskim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence vs. absence of clinically significant prostate cancer on prostate biopsy (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021; AzTrials last refreshed its copy on 2 Nov 2026.