Prostate Cancer MetastaticNCT04660617
A Multi-omics Study of Metastatic Prostate Cancer (MOSMPCA)
An observational study of Prostate Cancer Metastatic, run by West China Hospital.
Trial summary
The investigators plan to perform multi-omics technologies, including genomic, transcriptomic, epigenomic and proteomic methods, in patients with metastatic prostate cancer, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Apr 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary metastatic prostate cancer are potentially eligible for the current study.
Who may be able to join
- Pathological confirmation of prostate cancer
- Age: ≥40 years old
- Bone or visceral metastatic disease confirmed by image examination.
- Written informed consent
Who cannot join
- Patients harbouring other types of cancer besides prostate cancer
Trial locations and contacts
No sites are listed yet.
About this study
The investigators plan to perform multi-omics technologies, including genomic, transcriptomic, epigenomic and proteomic methods, in patients with metastatic prostate cancer, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
Read the detailed description
Prostate cancer is the commonest malignancy and the second leading cause of tumor-related death among males worldwide. Though patients with early stage prostate cancer can obtain satisfactory therapeutic efficacy from radical prostatectomy or radiotherapy, the prognosis of men with metastatic prostate cancer (mPCa), especially metastatic castration-resistant prostate cancer (mCRPC), is still poor. Recent years have witnessed the rapid development of the high-throughput technologies, including genomic, transcriptomic, epigenomic and proteomic methods. These techniques are promising in uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
In the current prospective study, the investigators plan to perform multi-omics technologies in patients with mPCa, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Genomic sequencing, Transcriptome sequencing, Epigenetics, Metabonomics, Immunohistochemical, Multi-omics Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic profiling results
Mutation identified via whole-genome sequencing will be recored.
Measured: From baseline (initial diagnosis of PCa), until study completion (48 months)
Transcriptional profiling results
Determining the transcriptomic information of metastatic prostate cancer by performing whole transcriptome sequencing
Measured: From baseline (initial diagnosis of PCa), until study completion (48 months)
Epigenomic profiling results
Determining the epigenomic status of specific genes by performing DNA-methylation sequencing
Measured: From baseline (initial diagnosis of PCa), until study completion (48 months)
Secondary outcomes (1)
Protein expression results
Determing the expression status of centain proteins by performing immunohistochemistry in prostate biopsy specimen
Measured: From baseline (initial diagnosis of PCa), until study completion (48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Aug 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Zeng, West China Hospital
- Investigators
- Hao Zeng, Dr., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660617
- Sponsor's protocol ID
- MOSMPCA
- Status last verified
- May 2021
- First submitted
- 1 Nov 2020
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Study of Metastatic Prostate Cancer (MOSMPCA)
- ClinicalTrials.gov ID
- NCT04660617
- Acronym / sponsor ID
- MOSMPCA
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Genomic sequencing, Transcriptome sequencing, Epigenetics, Metabonomics, Immunohistochemical, Multi-omics Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to perform multi-omics technologies, including genomic, transcriptomic, epigenomic and proteomic methods, in patients with metastatic prostate cancer, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
Detailed description
Prostate cancer is the commonest malignancy and the second leading cause of tumor-related death among males worldwide. Though patients with early stage prostate cancer can obtain satisfactory therapeutic efficacy from radical prostatectomy or radiotherapy, the prognosis of men with metastatic prostate cancer (mPCa), especially metastatic castration-resistant prostate cancer (mCRPC), is still poor. Recent years have witnessed the rapid development of the high-throughput technologies, including genomic, transcriptomic, epigenomic and proteomic methods. These techniques are promising in uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
In the current prospective study, the investigators plan to perform multi-omics technologies in patients with mPCa, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary metastatic prostate cancer are potentially eligible for the current study.
Key inclusion criteria (4 listed)
- Pathological confirmation of prostate cancer
- Age: ≥40 years old
- Bone or visceral metastatic disease confirmed by image examination.
- Written informed consent
Key exclusion criteria (1 listed)
- Patients harbouring other types of cancer besides prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic profiling results
Time frame: From baseline (initial diagnosis of PCa), until study completion (48 months)
Mutation identified via whole-genome sequencing will be recored.
Transcriptional profiling results
Time frame: From baseline (initial diagnosis of PCa), until study completion (48 months)
Determining the transcriptomic information of metastatic prostate cancer by performing whole transcriptome sequencing
Epigenomic profiling results
Time frame: From baseline (initial diagnosis of PCa), until study completion (48 months)
Determining the epigenomic status of specific genes by performing DNA-methylation sequencing
1 secondary outcome
Protein expression results
Time frame: From baseline (initial diagnosis of PCa), until study completion (48 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Zeng, Dr. principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Metastatic, run by West China Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinge Zhao, Dr. (86 13679017572, jingezhao@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic profiling results (time frame: From baseline (initial diagnosis of PCa), until study completion (48 months)). 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?
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 11 May 2021.