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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест PROSTEST
  BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Первичные конечные точки

• Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy [Срок оценки: 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.]

Вторичные конечные точки (1)

• Diagnostics metrics for the PROSTest [Срок оценки: 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.]

Критерии участия

Критерии включения

• elevated PSA and/or abnormal digital rectal examination

Критерии исключения

• Previous Prostate cancer diagnosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Wren Laboratories — Branford

Публикации

• 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 41463159
• 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 41129487
• 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 40970770
• 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 39838708

Идентификаторы

NCT: NCT07454603 · WREN_REGISTER_03 · WREN_010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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