An observational study in Prostate Cancer, Urology and Prostate Cancer (Diagnosis), sponsored by Wren Laboratories LLC. Recruiting at 1 site in United States. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Wren Laboratories LLC · Observational
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.
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. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group.
Endpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI.
Trial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately [1,500] participants.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Wren Laboratories LLC is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Men at risk for PCa based on age and or elevated PSA/abnormal DRE.
Exclusion Criteria:
BLOOD SAMPLE FOR PROSTEST MEASUREMENT
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
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.
Time frame: 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.
Diagnostics metrics for the PROSTest
Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.
Time frame: 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.
Plan to share: Undecided — We are establishing a DFR for this.
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