Clinically Actionable Tumor-Associated Antigens in Prostate Cancer

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.

NCT Number	NCT07597369
Lead Sponsor	Peking University First Hospital
Conditions	Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Cancer (mCRPC)
Enrollment	1,600 participants
Start Date	2026-01-01
Primary Completion	2029-01-01 (estimated)
Study Completion	2029-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-15