Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,600

participants targeted

Target at P75+ for all trials

Timeline

32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress13%

Jan 2026Jan 2029

Study Start

First participant enrolled

January 1, 2026

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 19, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Prostate Cancer Metastatic Prostate Cancer Metastatic Prostate Cancer (mCRPC)

Keywords

ADCmCRPCNEPCCSPC

Outcome Measures

Primary Outcomes (2)

Expression Profile in the Retrospective Prostate Cancer Cohort
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.
Baseline (at time of metastatic site sample acquisition)
Validation in the Prospective Cohort
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.
From date of prospective cohort enrollment until death from any cause, assessed up to 3 years

Secondary Outcomes (4)

Target Expression Difference: Primary Tumor vs. Paired Metastasis
Baseline (at time of matched sample acquisition)
Target Expression Difference: Across Different Metastatic Sites
Baseline
Target Expression in Special Clinicopathological Subtypes (Subgroup Analysis)
Baseline
Prognostic Association in Retrospective Prostate Cancer Cohort
From date of radical prostatectomy until biochemical recurrence, metastasis, or death, assessed up to 10 years

Other Outcomes (1)

Co-expression and Complementary Expression Patterns of ADC Targets
Baseline

Study Arms (5)

Primary Tumor Cohort

This retrospective cohort consists of patients with prostate cancer (encompassing castration-sensitive \[CSPC\], castration-resistant \[CRPC\] disease states, and those with special clinicopathological subtypes) for whom primary tumor tissue (from biopsy or radical prostatectomy) is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered.