AzTrials
AzTrials

Metastatic Hormone-Sensitive Prostate CancerPhase 2NCT07795177

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 Phase 2 study testing ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide) in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Anhui Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 to 85 years, men only
What is being tested?
ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Oct 2026to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheng Tai, M.D. contact

86-18355159268 ext. 0551-62922234

Taishengwk@163.com

Hongzhi Wang, M.D. contact

86-18846156838 ext. 0551-62922234

wanghongzhi0830@163.com

China1 site

  • Universitythe First Affiliatedhospital of Anhuimedical

    Hefei, Anhui, 230022

    Sheng Tai, M.D., 86-18355159268 ext. 0551-62922234, Taishengwk@163.com

    Hongzhi Wang, M.D., 86-18846156838 ext. 0551-62922234, wanghongzhi0830@163.com

Other trials in China

About this study

Official 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.

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.

Read the detailed description

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.

Being tested
ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
Keywords
Metastatic hormone-sensitive prostate cancer (mHSPC), Spatial multi-omics, ADT combined with androgen receptor pathway inhibitors (ADT+ARPI), Treatment response prediction model, Precision medicine / individualized therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called ADT plus abiraterone, ADT plus Apalutamide, ADT plus Enzalutamide, ADT plus 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 groups in NCT07795177
Study groupRoleWhat they receive
Newly diagnosed mHSPC patients who meet the inclusion criteriaExperimentalEligible 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
Receives: Drug: ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical Progression-Free Survival (bPFS)

    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.

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

  2. Overall Survival (OS)

    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.

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

Secondary outcomes (4)

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

    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.

    Measured: Baseline (at enrollment, from biopsy tissue).

  2. Spatial Gene Expression Signatures Measured by Xenium Platform

    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.

    Measured: Baseline (at enrollment).

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

    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.

    Measured: Baseline (at enrollment).

  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 ）

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
* Patient recruitment and enrollment (targeting approximately 40 patients). * Pre-treatment sample collection and spatial multi-omics profiling. * Patients receiving ADT combined with ARPI therapy. ④ Regular follow-up and collection of efficacy data. ⑤ Integration of spatial multi-omics data with clinical efficacy data. ⑥ Screening for spatial molecular biomarkers predictive of treatment response. ⑦ Construction and validation of a predictive efficacy model.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795177
Sponsor's protocol ID
KY2026-09-81
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.

Publications

  • 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.

    PubMed 41625480

  • 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.

    PubMed 41651176

  • 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.

    PubMed 41529384

  • 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.

    PubMed 36055231

  • 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.

    PubMed 40677104

  • 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.

    PubMed 39293393

  • 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.

    PubMed 41228234

  • 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.

    PubMed 41296089

  • 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.

    PubMed 39643549

  • 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.

    PubMed 38824003

  • 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.

    PubMed 41623173

  • 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.

    PubMed 41779146

  • 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.

    PubMed 39857987

  • 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.

    PubMed 41062343

  • 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.

    PubMed 29723398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide) in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Anhui Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheng Tai, M.D. (86-18355159268 ext. 0551-62922234, Taishengwk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07795177, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in