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Clinical Trials/NCT05577689
NCT05577689
Recruiting
Not Applicable

Combining Multi-omics Analysis and Organoid Models to Search for Novel Therapy Target in Metastatic Prostate Cancer

Fudan University1 site in 1 country100 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Neoplasms
Sponsor
Fudan University
Enrollment
100
Locations
1
Primary Endpoint
Multiple omics features
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The aim of this study is to use multiomics sequencing to explore the molecular characteristics of metastatic prostate cancer (mPCa), especially metastatic castration-resistant prostate cancer (mCRPC). At the same time, mCRPC models will be constructed, including organoids and animal models, serving as a basic and translational research platform to help identify novel drug targets for mPCa.

Detailed Description

Although substantial progress in treatments for prostate cancer have been made in the past decades, distant metastasis and drug resistance remained a major cause of prostate cancer-related deaths. The five-year survival rate for men with mPCa was only 30% and all patients with mPCa would inevitably progress to the castration-resistant stage with limited therapeutic chance. In China, the current situation is more worrying, with rapidly increasing PCa incidence and higher proportion of mPCa diagnosed compared with the Western nations (\~30% vs \~5%). Multiomics sequencing provides a promising strategy to discover the underlying molecular basis driving metastasis and resistance and identify the new treatment strategies for patients with mCRPC. The candidate drug target revealed by the multiomics sequencing could be further examined in the organoid and animal models, facilitating the clinical application from basic discovery. This study can establish a mCRPC research system to find the molecular mechanism and potential intervention targets of mCRPC, thereby paving the way for the discovery of new treatments for mCRPC patients.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
December 1, 2028
Last Updated
11 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ding-Wei Ye

Fudan University Shanghai Cancer Center

Fudan University

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed prostate cancer
  • metastatic disease confirmed by image examination
  • Patients who can undergo surgery or biopsy for prostate cancer
  • Able to provide informed consent

Exclusion Criteria

  • Patients diagnosed with other types of cancer besides prostate cancer
  • Not accessible to surgery sample
  • Patients fail to provide informed consent
  • Other situation that researchers think are unsuitable for this study

Outcomes

Primary Outcomes

Multiple omics features

Time Frame: 3 years

Multi-omics information including genetic profiling results, transcriptional profiling results and epigenomic profiling results will be collected and analyzed.

Organoids successfully generated from metastatic prostate cancer

Time Frame: 3 years

Successful isolation of prostate cancer organoids from surgical specimens of patients diagnosed with metastatic prostate cancer. We will calculate the culture efficiency and total number of organoids generated in our center.

Developing of biomarkers related to cancer metastasis and drug resistant

Time Frame: 3 years

To search for biomarkers related to tumor metastasis and resistance by performing multi-omics analysis to surgery specimens derived from patients with metastatic prostate cancer.

Secondary Outcomes

  • Response of the PDOX models to the selected anti-cancer compounds(3 years)
  • Animal models successfully generated from patient derived prostate cancer organoids(3 years)
  • Response of the prostate cancer organoids to the selected anti-cancer compounds(3 years)

Study Sites (1)

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