Tumor tissue profiling to predict treatment response in metastatic hormone-sensitive prostate cancer
Studies tumor samples to predict hormone therapy response in men with metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07795177, who can take part
Where in China
- Universitythe First Affiliatedhospital of AnhuimedicalHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anhui Medical University
- Trial code
- NCT07795177
- Record updated
- 31 August 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments); 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 other concurrent malignancies; Concurrent enrollment in other clinical trials; Histopathological diagnosis of neuroendocrine or small cell prostate cancer; History of immunodeficiency or organ transplantation; Other conditions that the investigator deems unsuitable for study enrollment; No definite distant metastases detected on imaging; Submitted biopsy samples fail to meet quality control requirements.