Clinical trial NCT04825002: Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
Official title: Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
biopsy
urine
biomarker
nanoparticle
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea
name: Korea Medial Device Development Fund grant funded by the Korean government
First posted: 2021-04-01
Enrollment: 800
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Presence vs. absence of clinically significant prostate cancer on prostate biopsy
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Presence vs. absence of overall prostate cancer
timeFrame: through study completion, an average of 3 year
measure: Optimal cutoff points for the each biomarker
timeFrame: through study completion, an average of 3 year
measure: Accuracy of each biomarker
timeFrame: through study completion, an average of 3 year
measure: Area Under Curve (Receiver operating curve) by multivariable linear regression model
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: