Clinical trial · Observational
A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth
NCT07454603CI-TRIAL-00123182PROSTest_STRATrecruitingClinicalTrials.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 prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.
Conditions
Conditions (3)
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 |
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Urology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROSTEST | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
- timeFrame
- Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
- description
- Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score \> or equal than 50 are predicted to be a prostate cancer. The expectation is that \>85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate \~400 individuals will be biopsy positive. Conversely, the expectation is that \>75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate \~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.
Secondary outcomes (1)
- measure
- Diagnostics metrics for the PROSTest
- timeFrame
- Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
- description
- Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * elevated PSA and/or abnormal digital rectal examination Exclusion Criteria: * Previous Prostate cancer diagnosis
References
Publications (4)
- BACKGROUNDRogers CG, Koduru SV, Gulati A, Halim AB. PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings. Cancers (Basel). 2025 Dec 6;17(24):3908. doi: 10.3390/cancers17243908. PMID 41463159
- BACKGROUNDKidd M, Rempega G, Kepinski M, Slomian S, Mlynarek K, Halim AB. Utility of the PROSTest, a Novel Blood-Based Molecular Assay, Versus PSA for Prostate Cancer Stratification and Detection of Disease. Prostate. 2026 Feb;86(3):307-313. doi: 10.1002/pros.70086. Epub 2025 Oct 23. PMID 41129487
- BACKGROUNDRahbar K, Rosin RD, Kidd M, Halim AB, Sartor O. PROSTest, a Multigene Liquid Biopsy Signature, Effectively Stratifies Patients With High PSA for Prostate Biopsy. Prostate. 2026 Jan;86(1):43-52. doi: 10.1002/pros.70052. Epub 2025 Sep 19. PMID 40970770
- BACKGROUNDRahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21. PMID 39838708