Prostate CarcinomaNCT03485794
Collection of Blood in Studying Metabolites in Patients With Prostate Cancer
An observational study of Prostate Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 2 Jan 2024
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with prostate cancer who are patients at the University of Southern California (USC) Westside Cancer Center
Who may be able to join
- All subjects will have histologically confirmed prostate cancer
- Provide written consent/authorization to participate in this study
- Have no signs or symptoms of active infection
- Exhibit a willingness to comply with the experimental procedures as outlined in this protocol
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients
This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting.
II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.
III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells [RBCs], and whole blood).
IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state.
OUTLINE:
Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.
- Conditions
- Prostate Carcinoma
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (biospecimen collection) | Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sample collection
The blood will be used to analyze the metabolites produced by white blood cells.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start14 Nov 2017
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Katz, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485794
- Sponsor's protocol ID
- 4P-17-8
- Other IDs
- NCI-2017-02078, 4P-17-8, P30CA014089
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2018
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03485794
- Acronym / sponsor ID
- 4P-17-8
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 2 Apr 2018 (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.
This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.
Detailed description
PRIMARY OBJECTIVES:
- Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting.
II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.
III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells [RBCs], and whole blood).
IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state.
OUTLINE:
Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisPatients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostate cancer who are patients at the University of Southern California (USC) Westside Cancer Center
Key inclusion criteria (4 listed)
- All subjects will have histologically confirmed prostate cancer
- Provide written consent/authorization to participate in this study
- Have no signs or symptoms of active infection
- Exhibit a willingness to comply with the experimental procedures as outlined in this protocol
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood | Procedure or surgery | Diagnostic (biospecimen collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (biospecimen collection) |
Primary outcome
Blood sample collection
Time frame: Baseline
The blood will be used to analyze the metabolites produced by white blood cells.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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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.
Jonathan Katz, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by University of Southern California at 1 site in United States.
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 0 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: stopped early, as of the sponsor's last update on 12 Aug 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 United States. 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?
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sample collection (time frame: Baseline). 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 12 Aug 2025.