Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05577689

Novel Therapy Target in Metastatic Prostate Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Yao Zhu, MD

CONTACT

[email protected]

+8615001818005

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue

Other

Tissue will be derived from patients during a standard of care procedure

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Animal models successfully generated from patient derived prostate cancer organoids

    Time frame: 3 years

    Prostate cancer organoids with clarified characteristics will be transplanted into mice to establish PDOX models.

  2. Response of the prostate cancer organoids to the selected anti-cancer compounds

    Time frame: 3 years

    Organoid that are successfully cultured and characteristic clarified will be treated with the selected compounds to test their anti-cancer activity.

  3. Response of the PDOX models to the selected anti-cancer compounds

    Time frame: 3 years

    PDOX models that successfully established will be treated with the selected compounds to test their anti-cancer activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: NTTPro

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Oct 13, 2022
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.