Clinical trial · Interventional
Detection of Clinically Significant Prostate Cancer Using a Urinary Multimarker Sensor
NCT04825002CI-TRIAL-00051016unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urinary multimarker sensor | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Urinary multimarker sensor arm
- description
- A urine of this group will be collected and measured using a newly developed urinary multimarker sensor (ANXA3, PSMA, ERG, ENG)
- interventionNames
- Diagnostic Test: Urinary multimarker sensor
Primary outcomes (1)
- measure
- Presence vs. absence of clinically significant prostate cancer on prostate biopsy
- timeFrame
- through study completion, an average of 3 year
- description
- (≥Gleason score 3+4)
Secondary outcomes (4)
- measure
- Presence vs. absence of overall prostate cancer
- timeFrame
- through study completion, an average of 3 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.