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.
ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
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
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age \> 18 years and \< 85 years.
2. Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
3. Imaging evidence of definite distant metastases (according to RECIST criteria).
4. Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4.
5. No prior hormonal therapy or other systemic anti-tumor regimens.
6. ECOG performance status 0-2, with an estimated life expectancy \> 6 months.
7. Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule.
Exclusion Criteria:
1. Histopathological diagnosis of neuroendocrine or small cell prostate cancer.
2. No definite distant metastases detected on imaging.
3. Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments).
4. Submitted biopsy samples fail to meet quality control requirements.
5. Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases.
6. Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions.
7. History of immunodeficiency or organ transplantation.
8. History of other concurrent malignancies.
9. Concurrent enrollment in other clinical trials.
10. Other conditions that the investigator deems unsuitable for study enrollment.
Primary outcome measure(s)
Biochemical Progression-Free Survival (bPFS) — 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.
Overall Survival (OS) — 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.
Trial sites (1)
Facility
City
Region
Status
Universitythe First Affiliatedhospital of Anhuimedical
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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