Clinical trial NCT05577689: Novel Therapy Target in Metastatic Prostate Cancer
Official title: Combining Multi-omics Analysis and Organoid Models to Search for Novel Therapy Target in Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Neoplasms
Keywords: prostate cancer
multi-omics
organoid
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic prostate cancer especially metastatic castration resistant prostate cancer will be recruited for this study.

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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed prostate cancer
2. metastatic disease confirmed by image examination
3. Patients who can undergo surgery or biopsy for prostate cancer
4. Able to provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Multiple omics features
timeFrame: 3 years
measure: Organoids successfully generated from metastatic prostate cancer
timeFrame: 3 years
measure: Developing of biomarkers related to cancer metastasis and drug resistant
timeFrame: 3 years
Secondary outcomes:
measure: Animal models successfully generated from patient derived prostate cancer organoids
timeFrame: 3 years
measure: Response of the prostate cancer organoids to the selected anti-cancer compounds
timeFrame: 3 years
measure: Response of the PDOX models to the selected anti-cancer compounds
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
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