Novel Therapy Target in Metastatic Prostate Cancer
- Conditions
- Prostate Neoplasms
- Interventions
- Other: Tissue
- Registration Number
- NCT05577689
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All patients Tissue There is only one arm in the trial
- Primary Outcome Measures
Name Time Method Multiple omics features 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 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 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 Outcome Measures
Name Time Method Response of the PDOX models to the selected anti-cancer compounds 3 years PDOX models that successfully established will be treated with the selected compounds to test their anti-cancer activity.
Animal models successfully generated from patient derived prostate cancer organoids 3 years Prostate cancer organoids with clarified characteristics will be transplanted into mice to establish PDOX models.
Response of the prostate cancer organoids to the selected anti-cancer compounds 3 years Organoid that are successfully cultured and characteristic clarified will be treated with the selected compounds to test their anti-cancer activity.