Clinically Actionable Tumor-Associated Antigens in Prostate Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Expression Profile in the Retrospective Prostate Cancer Cohort — Baseline (at time of metastatic site sample acquisition)
  The protein expression profiles of 15 tumor-associated antigens (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) and molecular subtype markers (AR, PSA, Syn, CgA, CD56, p53, RB1, and PTEN) in tumor tissues from the four retrospective site-based cohorts (Primary Tumor, Lymph Node Metastasis, Bone Metastasis, Visceral Metastasis). Measure: Expression level assessed by IHC score (0-3) , modified H-score (0-300) (positive expression defined as a H-score \> 20) for each target within each cohort.
• Validation in the Prospective Cohort — From date of prospective cohort enrollment until death from any cause, assessed up to 3 years
  The association between the expression status (positive/negative or H-score level) of prognostically significant ADC targets (identified in the retrospective cohort) and Overall Survival (OS) in the prospectively enrolled mCRPC validation cohort. This is a confirmatory analysis. Measure: Hazard Ratio (HR) with 95% Confidence Interval (CI) from Cox proportional hazards model.

Trial sites (1)

More Peking University First Hospital trials in China

Other trials for the same condition