Clinical trial · Interventional
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.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Hormone-Sensitive Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Newly diagnosed mHSPC patients who meet the inclusion criteria
- description
- Eligible patients will be enrolled after providing written informed consent. Individualized therapy (ADT plus abiraterone or other ARPIs) will be prescribed by the investigators according to each patient's financial situation, drug availability, and clinical needs, with regular follow-ups performed following routine real-world practice
- interventionNames
- Drug: ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
Primary outcomes (2)
- measure
- Biochemical Progression-Free Survival (bPFS)
- timeFrame
- From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (21)
- RESULTLv Y, Duan T, Song J, Liu S, Zhou Z, Ba Y, Weng S, Zuo A, Xu H, Luo P, Cheng Q, Zhang C, Ning J, Chen Y, Zhang Y, Liu Z, Han X. The Spatiotemporal Heterogeneity of Tumor-Associated Stromal Cells: Reprogramming Plasticity to Unlock Precision Cancer Immunotherapy. Cancer Commun (Lond). 2026 Jan 22;46:0002. doi: 10.34133/cancomm.0002. eCollection 2026. PMID 41625480
- RESULTWu Y, Chen T, Zuo J, Shen T, Dong L, Li F, Wang L, Tao Z. Multi-omics reveals that CTHRC1 secreted by cancer-associated fibroblasts promotes EMT by ITGA5/PI3K/AKT signaling pathway in HNSCC. Cell Signal. 2026 Jun;142:112409. doi: 10.1016/j.cellsig.2026.112409. Epub 2026 Feb 5. PMID 41651176
- RESULTHuang Y, Xiang C, Wang Y, Zhang W, Du L, Wang W, Shi G, Wang J. Spatial and single-cell multi-omics reveal pro-angiogenic THY1(+) fibroblast subtypes predicting prognosis in prostate cancer. Transl Oncol. 2026 Mar;65:102664. doi: 10.1016/j.tranon.2026.102664. Epub 2026 Jan 12. PMID 41529384
- RESULTAkhoundova D, Rubin MA. Clinical application of advanced multi-omics tumor profiling: Shaping precision oncology of the future. Cancer Cell. 2022 Sep 12;40(9):920-938. doi: 10.1016/j.ccell.2022.08.011. Epub 2022 Sep 1. PMID 36055231
- RESULTZhang Y, Yang C, Chen X, Wu L, Yuan Z, Zhang F, Qian BZ. Cancer therapy resistance from a spatial-omics perspective. Clin Transl Med. 2025 Jul;15(7):e70396. doi: 10.1002/ctm2.70396. PMID 40677104
- RESULTDu Y, Ding X, Ye Y. The spatial multi-omics revolution in cancer therapy: Precision redefined. Cell Rep Med. 2024 Sep 17;5(9):101740. doi: 10.1016/j.xcrm.2024.101740. PMID 39293393
- RESULTHuang J, Ojo A, Tsao S, Horowitz A, Kyprianou N, Tsao CK. Overcoming Immune Evasion in the Prostate Tumor Microenvironment: Novel Targeted Strategies to Improve Treatment Outcomes. Cancers (Basel). 2025 Oct 27;17(21):3441. doi: 10.3390/cancers17213441.