Novel Therapy Target in Metastatic Prostate Cancer

NCT ID: NCT05577689

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2028-12-01

Brief Summary

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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

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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.

Conditions

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Prostate Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

There is only one arm in the trial

Tissue

Intervention Type OTHER

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

Interventions

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Tissue

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ding-Wei Ye

Fudan University Shanghai Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yao Zhu

Role: CONTACT

+86 15001818005

Facility Contacts

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Yao Zhu, MD

Role: primary

+8615001818005

References

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Akhoundova D, Rubin MA. Clinical application of advanced multi-omics tumor profiling: Shaping precision oncology of the future. Cancer Cell. 2022 Sep 12;40(9):920-938. doi: 10.1016/j.ccell.2022.08.011. Epub 2022 Sep 1.

Reference Type BACKGROUND
PMID: 36055231 (View on PubMed)

Yerly L, Pich-Bavastro C, Di Domizio J, Wyss T, Tissot-Renaud S, Cangkrama M, Gilliet M, Werner S, Kuonen F. Integrated multi-omics reveals cellular and molecular interactions governing the invasive niche of basal cell carcinoma. Nat Commun. 2022 Aug 20;13(1):4897. doi: 10.1038/s41467-022-32670-w.

Reference Type BACKGROUND
PMID: 35986012 (View on PubMed)

Zhu Y, Mo M, Wei Y, Wu J, Pan J, Freedland SJ, Zheng Y, Ye D. Epidemiology and genomics of prostate cancer in Asian men. Nat Rev Urol. 2021 May;18(5):282-301. doi: 10.1038/s41585-021-00442-8. Epub 2021 Mar 10.

Reference Type BACKGROUND
PMID: 33692499 (View on PubMed)

Wei Y, Wu J, Gu W, Qin X, Dai B, Lin G, Gan H, Freedland SJ, Zhu Y, Ye D. Germline DNA Repair Gene Mutation Landscape in Chinese Prostate Cancer Patients. Eur Urol. 2019 Sep;76(3):280-283. doi: 10.1016/j.eururo.2019.06.004. Epub 2019 Jun 24.

Reference Type BACKGROUND
PMID: 31248605 (View on PubMed)

Gao D, Vela I, Sboner A, Iaquinta PJ, Karthaus WR, Gopalan A, Dowling C, Wanjala JN, Undvall EA, Arora VK, Wongvipat J, Kossai M, Ramazanoglu S, Barboza LP, Di W, Cao Z, Zhang QF, Sirota I, Ran L, MacDonald TY, Beltran H, Mosquera JM, Touijer KA, Scardino PT, Laudone VP, Curtis KR, Rathkopf DE, Morris MJ, Danila DC, Slovin SF, Solomon SB, Eastham JA, Chi P, Carver B, Rubin MA, Scher HI, Clevers H, Sawyers CL, Chen Y. Organoid cultures derived from patients with advanced prostate cancer. Cell. 2014 Sep 25;159(1):176-187. doi: 10.1016/j.cell.2014.08.016. Epub 2014 Sep 4.

Reference Type BACKGROUND
PMID: 25201530 (View on PubMed)

Guo C, Figueiredo I, Gurel B, Neeb A, Seed G, Crespo M, Carreira S, Rekowski J, Buroni L, Welti J, Bogdan D, Gallagher L, Sharp A, Fenor de la Maza MD, Rescigno P, Westaby D, Chandran K, Riisnaes R, Ferreira A, Miranda S, Cali B, Alimonti A, Bressan S, Nguyen AHT, Shen MM, Hawley JE, Obradovic A, Drake CG, Bertan C, Baker C, Tunariu N, Yuan W, de Bono JS. B7-H3 as a Therapeutic Target in Advanced Prostate Cancer. Eur Urol. 2023 Mar;83(3):224-238. doi: 10.1016/j.eururo.2022.09.004. Epub 2022 Sep 13.

Reference Type BACKGROUND
PMID: 36114082 (View on PubMed)

Other Identifiers

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PCa-Organoid

Identifier Type: -

Identifier Source: org_study_id

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