NCT07454603 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
| NCT ID | NCT07454603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wren Laboratories LLC |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2026-04-15 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * elevated PSA and/or abnormal digital rectal examination Exclusion Criteria: * Previous Prostate cancer diagnosis
Contact & Investigator
Abdel Halim, PharmD, PhD
STUDY CHAIR
Wren Laboratories
Frequently Asked Questions
Who can join the NCT07454603 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454603 currently recruiting?
Yes, NCT07454603 is actively recruiting participants. Contact the research team at mkidd@wrenlaboratories.com for enrollment information.
Where is the NCT07454603 trial being conducted?
This trial is being conducted at Branford, United States.
Who is sponsoring the NCT07454603 clinical trial?
NCT07454603 is sponsored by Wren Laboratories LLC. The principal investigator is Abdel Halim, PharmD, PhD at Wren Laboratories. The trial plans to enroll 1,500 participants.
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