Clinical trial · Observational
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
NCT04720599CI-TRIAL-00054205completedClinicalTrials.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 study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.
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 |
|---|---|---|---|
| Urologic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExoDx Prostate(IntelliScore) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical suspicion for prostate cancer * Elevated Prostate-specific Antigen between 2.0-10 ng/ mL * Scheduled for a initial prostate biopsy Exclusion Criteria: * Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. * History of prostate cancer. * History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment. * Known hepatitis status (all types) and/or HIV documented in patient's medical record. * Patients with history of concurrent renal/bladder tumors. * Prior MRI used in the decision to biopsy
References
Publications (2)
- DERIVEDKretschmer A, Kajau H, Margolis E, Tutrone R, Grimm T, Trottmann M, Stief C, Stoll G, Fischer CA, Flinspach C, Albrecht A, Meyer L, Priewasser T, Enderle D, Muller R, Torkler P, Alter J, Skog J, Noerholm M. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy. Sci Rep. 2022 Mar 21;12(1):4777. doi: 10.1038/s41598-022-08608-z. PMID 35314720
- DERIVEDKretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27. PMID 35084544