NCT07454603

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

February 2, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 2, 2026

Last Update Submit

March 2, 2026

Conditions

Prostate CancerUrologyProstate Cancer (Diagnosis)

Keywords

BIOPSYMRIPROSTATE CANCER

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • Diagnostics metrics for the PROSTest

    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.

Interventions

PROSTESTDIAGNOSTIC_TEST

BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Eligibility Criteria

Age45 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPROSTATE CANCER IS A MALE DISEASE
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men at risk for PCa based on age and or elevated PSA/abnormal DRE.

You may qualify if:

  • elevated PSA and/or abnormal digital rectal examination

You may not qualify if:

  • Previous Prostate cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wren Laboratories

Branford, Connecticut, 06405, United States

Location

Related Publications (4)

  • 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.

    PMID: 41463159BACKGROUND

  • 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.

    PMID: 41129487BACKGROUND

  • 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.

    PMID: 40970770BACKGROUND

  • 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.

    PMID: 39838708BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

WHOLE BLOOD

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdel Halim, PharmD, PhD

    Wren Laboratories

    STUDY CHAIR

Central Study Contacts

Mark Kidd, PhD

CONTACT

2038241128mkidd@wrenlaboratories.com

Tracy Auster, BS

CONTACT

2032083464tauster@wrenlaboratories.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

March 6, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

US(1)