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NCT Number: NCT07795177

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.

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.

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Key information

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

About this study

1、Baseline sample collection: Tumor tissues will be collected via prostate biopsy from enrolled patients. The specimens will be tripartite: one aliquot for standard histopathology, one for WES, and one for spatial multi-omic profiling (Xenium and PhenoCycler-Fusion).2、Follow-up: Patients will be assessed every 3 months during therapy, with CBC, biochemistry, sex hormones, and serum PSA. Prostate mpMRI will be repeated every 3 months. PSA testing frequency may be modified if PSA progression occurs. Follow-up continues until CRPC development or death.3、（1）Primary: Build a prognostic model integrating Xenium, WES, and PCF data.（2）Secondary: bPFS and OS.（3）Progression: PSA rise to ≥0.2 ng/mL confirmed on repeat testing after prior undetectable levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years and < 85 years.
  • Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
  • Imaging evidence of definite distant metastases (according to RECIST criteria).
  • Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4.
  • No prior hormonal therapy or other systemic anti-tumor regimens.
  • ECOG performance status 0-2, with an estimated life expectancy > 6 months.
  • Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule.

Exclusion criteria

  • Histopathological diagnosis of neuroendocrine or small cell prostate cancer.
  • No definite distant metastases detected on imaging.
  • Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments).
  • Submitted biopsy samples fail to meet quality control requirements.
  • Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases.
  • Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions.
  • History of immunodeficiency or organ transplantation.
  • History of other concurrent malignancies.
  • Concurrent enrollment in other clinical trials.
  • Other conditions that the investigator deems unsuitable for study enrollment.

Treatment and study plan

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

Drug

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

Other names: ADT plus abiraterone, ADT plus Apalutamide, ADT plus Enzalutamide, ADT plus Darolutamide, ADT plus rezvilutamide

Primary outcomes

  1. Biochemical Progression-Free Survival (bPFS)

    Time frame: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.

    Time from initiation of ADT plus ARPI therapy to biochemical progression or death from any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to ≥0.2 ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2 weeks apart. Participants without an event will be censored at the date of last follow-up.

  2. Overall Survival (OS)

    Time frame: From treatment initiation until death or last follow-up, assessed up to 24 months.

    Time from treatment initiation to death from any cause. Participants alive or lost to follow-up will be censored at the date last known alive.

Secondary outcomes

  1. Mutation Frequency of Key Genes Assessed by Whole-Exome Sequencing (WES)

    Time frame: Baseline (at enrollment, from biopsy tissue).

    Baseline tumor tissue from prostate biopsy will be analyzed by WES. The mutation status (including variant allele frequency) of AR, TP53, PTEN, RB1, and other relevant genes will be reported as the proportion of participants with each mutation.

  2. Spatial Gene Expression Signatures Measured by Xenium Platform

    Time frame: Baseline (at enrollment).

    Baseline biopsy tissue will be processed for Xenium in situ spatial transcriptomics. The average expression levels of a pre-specified gene panel (including AR-signaling and immune-related genes) in tumor, immune, and stromal compartments will be reported.

  3. Spatial Protein Marker Expression Measured by PhenoCycler-Fusion (PCF)

    Time frame: Baseline (at enrollment).

    Using cyclic immunofluorescence on baseline biopsy tissue, the platform quantifies the density (cells/mm²) and proportion of positive cells for a panel of protein markers (e.g., AR, PSMA, PD-L1, CD8, CD68) within the tumor microenvironment.

  4. Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-omics Prediction Model for 6-Month Undetectable PSA（ PSA <0.2 ng/mL ）

    Time frame: Baseline data used to predict outcome at 6 months after treatment initiation.

    Baseline WES, Xenium, and PCF data will be integrated using a machine-learning algorithm (e.g., random forest or LASSO-Cox) to build a model predicting Undetectable PSA at 6 months ( defined as serum PSA <0.2 ng/mL confirmed at two consecutive visits). Model performance will be evaluated by cross-validation, and the mean AUC with 95% confidence interval will be reported, along with sensitivity, specificity, and positive predictive value.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongzhi Wang, M.D.

CONTACT

[email protected]

86-18846156838 ext. 0551-62922234

Sheng Tai, M.D.

CONTACT

[email protected]

86-18355159268 ext. 0551-62922234

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

A Prospective Study Based on Spatial Multi-Omics for Predicting the Efficacy of Androgen Deprivation Therapy Combined With Second-Generation Novel Endocrine Therapeutic Agents in Metastatic Hormone-Sensitive Prostate Cancer.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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