Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

NCT04825002 | Unknown

• 1 other identifier: 2021-0305
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; biopsy; urine; biomarker; nanoparticle

Outcome Measures

Primary Outcomes (1)

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

  (≥Gleason score 3+4)

  through study completion, an average of 3 year

Secondary Outcomes (4)

• Presence vs. absence of overall prostate cancer

  through study completion, an average of 3 year

• Optimal cutoff points for the each biomarker

  through study completion, an average of 3 year

• Accuracy of each biomarker

  through study completion, an average of 3 year

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

  through study completion, an average of 3 year

Study Arms (1)

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)

Diagnostic Test: Urinary multimarker sensor

Interventions

Urinary multimarker sensor DIAGNOSTIC_TEST

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

Urinary multimarker sensor arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Biomaterials Research Center, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea: collaborator
• Korea Medial Device Development Fund grant funded by the Korean government: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Choung-Soo Kim, MD

CONTACT

82-2-3010-3734; cskim@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)