Clinical trial · Interventional
Decision Impact Trial of the ExoDx Prostate (IntelliScore)
A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
NCT03235687CI-TRIAL-00058311unknownN/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 this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
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 the 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)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.
- interventionNames
- Diagnostic Test: ExoDx Prostate (IntelliScore)
- type
- NO_INTERVENTION
- label
- Cohort B
- description
- Patients randomized to Cohort B will proceed with conventional standard of care.
Primary outcomes (1)
- measure
- Evaluate performance of the ExoDx Prostate(IntelliScore)
- timeFrame
- 6 Months
- description
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. * Known hepatitis (all types) and/or HIV documented in patient's medical record. * Patients with history of concurrent renal/bladder tumors.
References
Publications (3)
- RESULTTutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7. PMID 32382078
- DERIVEDTutrone R, Lowentritt B, Neuman B, Donovan MJ, Hallmark E, Cole TJ, Yao Y, Biesecker C, Kumar S, Verma V, Sant GR, Alter J, Skog J. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):596-601. doi: 10.1038/s41391-023-00675-1. Epub 2023 May 16. PMID 37193776
- 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