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 (PROSTest_STRAT)
August 19, 2026 updated by: Wren Laboratories LLC
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mark Kidd, PhD
- Phone Number: 2038241128
- Email: mkidd@wrenlaboratories.com
Study Contact Backup
- Name: Tracy Auster, BS
- Phone Number: 2032083464
- Email: tauster@wrenlaboratories.com
Study Locations
-
-
Connecticut
-
Branford, Connecticut, United States, 06405
- Recruiting
- Wren Laboratories
-
Contact:
- Mark Kidd, PhD
- Phone Number: 2038241128
- Email: mkidd@wrenlaboratories.com
-
Contact:
- Tracy Auster, BS
- Phone Number: 2032083464
- Email: tauster@wrenlaboratories.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Men at risk for PCa based on age and or elevated PSA/abnormal DRE.
Description
Inclusion Criteria:
- elevated PSA and/or abnormal digital rectal examination
Exclusion Criteria:
- Previous Prostate cancer diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
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.
|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostics metrics for the PROSTest
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.
|
Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abdel Halim, PharmD, PhD, Wren Laboratories
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rogers 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.
- Kidd 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.
- Rahbar 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.
- Rahbar 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
February 2, 2026
First Submitted That Met QC Criteria
March 2, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 19, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WREN_REGISTER_03
- WREN_010 (Registry Identifier: PROSTest_Stratification_Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We are establishing a DFR for this.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.