Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-06 @ 1:19 AM
Study NCT ID:
NCT07454603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer
Sponsor:
Wren Laboratories LLC
Organization:
Study Overview
Official Title:
A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTest_STRAT
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WREN_010 | REGISTRY | PROSTest_Stratification_Registry | View |