NCT03485794

Brief 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. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

6.1 years

First QC Date

March 26, 2018

Last Update Submit

August 7, 2025

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Blood sample collection

    The blood will be used to analyze the metabolites produced by white blood cells.

    Baseline

Study Arms (1)

Diagnostic (biospecimen collection)

Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Procedure: Biospecimen CollectionOther: Laboratory Biomarker Analysis

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood

Diagnostic (biospecimen collection)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Diagnostic (biospecimen collection)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with prostate cancer who are patients at the University of Southern California (USC) Westside Cancer Center

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMCs

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jonathan Katz, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

November 14, 2017

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

US(1)