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.

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.

Timeline

Start

2026-10-01

Primary completion

2028-04-30

Completion

2028-06-30

Publications

• Results Lv 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.
• Results Wu 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.
• Results Huang 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.
• Results Akhoundova 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.
• Results Zhang 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.
• Results Du 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.
• Results Huang 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.
• Results Li M, Kwantwi LB, Wang C, Xiao Q. Tumor microenvironment-mediated immune evasion and resistance in prostate cancer: mechanisms, cross-talk, and therapeutic opportunities. Clin Exp Med. 2025 Nov 26;26(1):60. doi: 10.1007/s10238-025-01944-0.
• Results Hoeh B, Wenzel M, Tian Z, Karakiewicz PI, Saad F, Steuber T, Graefen M, Tilki D, Herout R, Thomas C, Chun FK, Mandel P. Triplet or Doublet Therapy in Metastatic Hormone-sensitive Prostate Cancer Patients: An Updated Network Meta-analysis Including ARANOTE Data. Eur Urol Focus. 2025 Mar;11(2):386-390. doi: 10.1016/j.euf.2024.11.004. Epub 2024 Dec 5.
• Results Baboudjian M, Peyrottes A, Dariane C, Fromont G, Denis JA, Fiard G, Kassab D, Ladoire S, Lehmann-Che J, Ploussard G, Roupret M, Barthelemy P, Roubaud G, Lamy PJ. Circulating Biomarkers Predictive of Treatment Response in Patients with Hormone-sensitive or Castration-resistant Metastatic Prostate Cancer: A Systematic Review. Eur Urol Oncol. 2024 Dec;7(6):1228-1245. doi: 10.1016/j.euo.2024.05.003. Epub 2024 May 31.
• Results Bernard-Tessier A, Beltran H. Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine. J Clin Invest. 2026 Feb 2;136(3):e200920. doi: 10.1172/JCI200920. eCollection 2026 Feb 2.
• Results Grimm MO, Leucht K, Marx M, Sperling M, Albarghouth MH. [Treatment of metastatic hormone-sensitive prostate cancer]. Urologie. 2026 Mar;65(3):324-335. doi: 10.1007/s00120-026-02798-4. Epub 2026 Mar 4. German.
• Results Matsukawa A, Litterio G, Cormio A, Miszczyk M, Kardoust Parizi M, Fazekas T, Tsuboi I, Mancon S, Schulz RJ, Laukhtina E, Rajwa P, Mori K, Chlosta P, Marchioni M, Schips L, Miki J, Kimura T, Shariat SF, Yanagisawa T. An Updated Systematic Review and Network Meta-Analysis of First-Line Triplet vs. Doublet Therapies for Metastatic Hormone-Sensitive Prostate Cancer. Cancers (Basel). 2025 Jan 9;17(2):205. doi: 10.3390/cancers17020205.
• Results Nicoletti R, Liu AQ, Evans-Axelsson S, Golozar A, Beyer K, Meulder B, Campi R, Gacci M, Teoh JY, Steinbesser C, Hijazy A, Harbachou A, Brash JT, Willemse PM, Murtola T, Roobol MJ, Sierra JM, Bjartell A, Merseburger AS, Rajwa P, Cornford P, Abbott T, Ndow J, Rivas JG, Davies E, Feng Q, Snijder R; PIONEER + consortium. Treatment Trajectories in Metastatic Hormone-sensitive Prostate Cancer: A PIONEER+ Big Data Analysis. Eur Urol Oncol. 2025 Oct;8(5):1340-1349. doi: 10.1016/j.euo.2025.08.007. Epub 2025 Oct 8.
• Results Helgstrand JT, Roder MA, Klemann N, Toft BG, Lichtensztajn DY, Brooks JD, Brasso K, Vainer B, Iversen P. Trends in incidence and 5-year mortality in men with newly diagnosed, metastatic prostate cancer-A population-based analysis of 2 national cohorts. Cancer. 2018 Jul 15;124(14):2931-2938. doi: 10.1002/cncr.31384. Epub 2018 May 3.
• Results Wang B, Liu Z, Yang L, Zhang X. Advances in the treatment of metastatic prostate cancer in China. Cancer Biol Med. 2025 May 19;22(5):433-8. doi: 10.20892/j.issn.2095-3941.2025.0065. No abstract available.
• Results Xue M, Guo W, Zhou Y, Meng J, Xi Y, Pan L, Ye Y, Zeng Y, Che Z, Zhang L, Ye P, Conde J, Lin Q, Jin W; GBD 2021 China Urological Cancers Burden and Forecasting Collaborators. Age-sex-specific burden of urological cancers attributable to risk factors in China and its provinces, 1990-2021, and forecasts with scenarios simulation: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Reg Health West Pac. 2025 Mar 18;56:101517. doi: 10.1016/j.lanwpc.2025.101517. eCollection 2025 Mar.
• Results Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
• Results Kyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.
• Results Kroon J, Kooijman S, Cho NJ, Storm G, van der Pluijm G. Improving Taxane-Based Chemotherapy in Castration-Resistant Prostate Cancer. Trends Pharmacol Sci. 2016 Jun;37(6):451-462. doi: 10.1016/j.tips.2016.03.003. Epub 2016 Apr 8.
• Results Kimura T, Egawa S. Epidemiology of prostate cancer in Asian countries. Int J Urol. 2018 Jun;25(6):524-531. doi: 10.1111/iju.13593. Epub 2018 May 8.

Drugs

Indications