NCT07795177Not yet recruitingPhase 2
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 · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Anhui Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT07795177
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Oct 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- No definite distant metastases detected on imaging.
- Submitted biopsy samples fail to meet quality control requirements.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitythe First Affiliatedhospital of Anhuimedical Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.