MedTrace Logo

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

NCT07454603 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

PROSTEST

BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Sponsors & Collaborators

  • Wren Laboratories LLC

    lead INDUSTRY

Principal Investigators

  • Abdel Halim, PharmD, PhD · Wren Laboratories

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2027-02-28
Completion
2027-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454603 on ClinicalTrials.gov