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NCT07597369

Clinically Actionable Tumor-Associated Antigens in Prostate Cancer

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. primary and different metastatic types,HSPC and CRPC, PC with neuroendocrine differentiation, cribriform/intraductal carcinoma). The main questions it aims to answer are: 1. What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer? 2. Can the prognostic value of these targets (e.g. association with overall survival) identified in a retrospective cohort be validated in an independent prospective cohort? Researchers will head-to-head compare the expression levels among different targets and across different disease stages/metastatic site. Researchers will also assess whether the targets showing prognostic significance in the retrospective cohort can also predict survival outcomes in the prospective cohort. Participants in the retrospective cohort have already provided archived tissue samples and clinical data. Participants in the prospective cohort (metastatic prostate cancer patients) will be invited to provide residual tumor tissue samples obtained during standard care and will be followed up regularly for clinical outcomes.

Official title: Expression Profiles And Prognostic Implications Of Clinically Actionable Tumor-Associated Antigens Across Diverse Clinicopathological Subtypes of Prostate Cancer: a Bidirectional Cohort Study

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1600

Start Date

2026-01-01

Completion Date

2029-01-01

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

OTHER

Immunohistochemistry (IHC) Staining and Analysis

Immunohistochemistry staining will be performed on formalin-fixed, paraffin-embedded (FFPE) prostate cancer tissue sections to quantitatively assess the expression levels of eight membrane protein targets: PSMA, HER2, TROP2, NECTIN4, DLL3, STEAP1, B7-H3, and PDL1. This is a laboratory-based biomarker analysis and does not constitute a therapeutic intervention for participants.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China