Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Prostate Cancer Clinical Trial

Official title:

Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825002
• Other study ID #: 2021-0305
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Asan Medical Center
• Contact: Choung-Soo Kim, MD
• Phone: 82-2-3010-3734
• Email: cskim[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators hypothesize that urinary multimarker sensor will help to avoid unnecessary prostate biopsy while detect the clinically significant cancers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence vs. absence of clinically significant prostate cancer on prostate biopsy	(=Gleason score 3+4)	through study completion, an average of 3 year
Secondary	Presence vs. absence of overall prostate cancer	presence or absence of prostate cancer at prostate biopsy	through study completion, an average of 3 year
Secondary	Optimal cutoff points for the each biomarker	cutoff points for each biomarker (ANXA3, PSMA, ERG, ENG)	through study completion, an average of 3 year
Secondary	Accuracy of each biomarker	sensitivity, specificity, positive/negative predictive value	through study completion, an average of 3 year
Secondary	Area Under Curve (Receiver operating curve) by multivariable linear regression model	Area Under Curve for each biomarker alone or combination	through study completion, an average of 3 year