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NCT Number: NCT07454603

A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer (Diagnosis) Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Urology

Age range

45 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elevated PSA and/or abnormal digital rectal examination

Exclusion criteria

  • Previous Prostate cancer diagnosis

Treatment and study plan

PROSTEST

Diagnostic Test

BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Kidd, PhD

CONTACT

[email protected]

2038241128

Tracy Auster, BS

CONTACT

[email protected]

2032083464

Sponsors and collaborators

Lead sponsor

Wren Laboratories LLC

Industry

Registry information

Acronym: PROSTest_STRAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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