Prostate Cancer Clinical Trial
Official title:
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
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 |
Korea, Republic of,
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 |
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