AzTrials
AzTrials

Prostate NeoplasmsNTTProNCT05577689

Novel Therapy Target in Metastatic Prostate Cancer

An observational study of Prostate Neoplasms, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasms
What is being tested?
Tissue
How many people
100 participants
Where
1 siteChina
Study dates
1 Aug 2023to 1 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with metastatic prostate cancer especially metastatic castration resistant prostate cancer will be recruited for this study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yao Zhu contact

+86 15001818005

mailzhuyao@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Yao Zhu, MD, +8615001818005, zhuyao@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Combining Multi-omics Analysis and Organoid Models to Search for 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.

Read the 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.

Being tested
Tissue
Keywords
prostate cancer, multi-omics, organoid
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TissueOther

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

Study groups in NCT05577689
Study groupRoleWhat they receive
All patientsThere is only one arm in the trial
Receives: Other: Tissue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multiple omics features

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

    Measured: 3 years

  2. Organoids successfully generated from metastatic prostate cancer

    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.

    Measured: 3 years

  3. Developing of biomarkers related to cancer metastasis and drug resistant

    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.

    Measured: 3 years

Secondary outcomes (3)

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

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

    Measured: 3 years

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

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

    Measured: 3 years

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

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start1 Aug 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577689
Sponsor's protocol ID
PCa-Organoid
Acronym
NTTPro
Status last verified
Jun 2025
First submitted
10 Oct 2022
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36055231

  • 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.

    PubMed 35986012

  • 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.

    PubMed 33692499

  • 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.

    PubMed 31248605

  • 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.

    PubMed 25201530

  • 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.

    PubMed 36114082

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Neoplasms, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yao Zhu (+86 15001818005, mailzhuyao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiple omics features (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05577689, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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