Clinically Actionable Tumor-Associated Antigens in Prostate Cancer

NCT07597369 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

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Entities

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 NCT07597369 on ClinicalTrials.gov