Status:
UNKNOWN
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
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
Conditions:
Prostate Cancer
Eligibility:
MALE
50-80 years
Phase:
NA
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 can...
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 Inst...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04825002
Start Date
March 22 2021
End Date
December 31 2023
Last Update
April 1 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736