Clinical trial · Interventional
MyProstateScore Equivalency With and Without DRE
Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
NCT05700370CI-TRIAL-00063437unknownN/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)
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.
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 |
|---|---|---|---|
| MyProstateScore | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sample collected with preceding DRE, then without
- description
- All subjects participate in the control and experimental collection event sequentially. The control group will consist of urine samples collected post-DRE, and the experimental group will consist of urine samples collected by the same subjects without preceding DRE.
- interventionNames
- Diagnostic Test: MyProstateScore
Primary outcomes (2)
- measure
- MPS equivalency with and without DRE
- timeFrame
- Study participation will span 8 days
- description
- The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE.
- measure
- MPS validity rate with and without DRE
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is a candidate for prostate biopsy (Bx) * If Bx naïve and ≤75yo then PSA 3-10 ng/mL * If Bx naïve and \>75yo then PSA 4-10 ng/mL * If prior negative Bx then PSA may exceed 10 ng/mL * If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (\>75yo) are acceptable Exclusion Criteria: \- Prior diagnosis of prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.