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A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.

NCT07795177 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-31

No results posted yet for this study

Summary

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

Conditions

Interventions

DRUG

ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)

The spatial heterogeneity of the tumor microenvironment in mHSPC-encompassing immune cell infiltration patterns, tumor-stroma interface features, and the regional activation status of critical signaling pathways-is intimately linked to clinical outcomes with ADT plus ARPI therapy. Through comprehensive spatial multi-omic profiling, these spatial attributes can be systematically dissected to uncover pivotal predictive biomarkers, facilitate the development of accurate response prediction models, and ultimately guide personalized therapeutic strategies for patients with mHSPC

Sponsors & Collaborators

  • Anhui Medical University

    lead OTHER

Principal Investigators

  • Sheng Tai, M.D. · The First Affiliated Hospital of Anhui Medical University

  • Hongzhi Wang, M.D. · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-04-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07795177 on ClinicalTrials.gov