Clinical trial · Observational
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)
Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.
- 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 this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).
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 |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExoDx Prostate Intelliscore | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Enroll up to 500 patients to confirm performance of ExoDx Prostate IntelliScore (EPI) for men scheduled for initial biopsy. The treating physician will collect a urine sample from from a consented subject to test before their scheduled prostate biopsy (during your established clinic visit).
- label
- Cohort 2
- description
- Enroll up to 500 patients to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy. The treating physician will collect a urine sample for testing and 2 weeks later discuss whether to perform a prostate biopsy with the subject knowing the results of the urine test and comparing them to the overall consensus report from Cohort 1 as well as other clinical factors the treating physician would otherwise use to determine whether they should have a prostate biopsy.
- interventionNames
- Diagnostic Test: ExoDx Prostate Intelliscore
Primary outcomes (1)
- measure
- Confirm performance of the ExoDx Prostate IntelliScore
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 50 years of age * Clinical suspicion for prostate cancer * Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL * No clinical history of a prior negative biopsy Exclusion Criteria: * History of prior prostate biopsy. * Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment. * 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 (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment. * No known hepatitis (all types) and/or HIV documented in patient's medical record. * Patients with history of concurrent renal/bladder tumors.
References
Publications (3)
- RESULTDonovan MJ, Noerholm M, Bentink S, Belzer S, Skog J, O'Neill V, Cochran JS, Brown GA. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis. 2015 Dec;18(4):370-5. doi: 10.1038/pcan.2015.40. Epub 2015 Sep 8. PMID 26345389
- 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
- DERIVEDMcKiernan J, Donovan MJ, Margolis E, Partin A, Carter B, Brown G, Torkler P, Noerholm M, Skog J, Shore N, Andriole G, Thompson I, Carroll P. A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer in Patients with Prostate-specific Antigen 2-10ng/ml at Initial Biopsy. Eur Urol. 2018 Dec;74(6):731-738. doi: 10.1016/j.eururo.2018.08.019. Epub 2018 Sep 17. PMID 30237023