Study Stopped
Sponsor decided not to pursue study
Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer
Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
4 other identifiers
observational
24
1 country
1
Brief Summary
This research trial studies molecular characterization of circulating tumor cells (CTCs) and circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. Studying samples of blood and plasma collected from patients with prostate cancer before, during, and/or after treatment in the laboratory may help doctors learn more about changes that occur in DNA and identify the development of drug resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2014
CompletedFirst Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2016
CompletedApril 17, 2017
April 1, 2017
1.5 years
February 17, 2015
April 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of patients with elevated CTCs
Descriptive statistics will also be applied to summarize levels of CTC numbers. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data. The proportion of patients with elevated CTCs will be estimated using a 90% confidence interval.
Up to 2 years
Expression of individual markers according to clinical stage, serum PSA, and pathologic grade
Descriptive statistics will also be applied to summarize expression of individual markers according to clinical variables (clinical stage, serum PSA, pathologic grade, etc). The predominant statistical approaches will include correlation indices and mean comparisons to explore relations within the full data set and between clinical variables and expression data.
Up to 2 years
Study Arms (2)
Group I (retrospective analysis)
Previously collected plasma samples are analyzed for ctDNA via PCR and NSG.
Group II (prospective analysis)
Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, RNA expression, and ctDNA via PCR and NSG.
Interventions
Undergo collection of blood samples
Correlative studies
Eligibility Criteria
Patients with metastatic and/or hormone-resistant prostate cancer consented under University of Southern California (USC) protocols IRB numbers 10-00006 and 11-004500 or treated at the USC/Westside Cancer Center, USC/Norris Comprehensive Cancer Center, or LAC + USC Medical Center.
You may qualify if:
- GROUP I: Samples for Group I will be selected from existing sample sets obtained from concluded studies (USC IRB #'s 10-00006 and 11-00450)
- GROUP I: Excess plasma collected and stored in these trials from patients treated with abiraterone or enzalutamide will be used for the molecular analysis of the current protocol
- GROUP II: The second group of samples (Group 2) will involve prospective collection of peripheral blood from patients with advanced, treatment-resistant metastatic prostate cancer
- GROUP II: Histologic documentation of prostate cancer
- GROUP II: Metastatic cancer diagnosed by imaging and other clinical criteria
- GROUP II: Treatment-resistance determined by at least one of the following factors: increase in prostate-specific antigen (PSA) value over a baseline measurement; increase in size or number of metastatic deposits determined on imaging; and/or progression in cancer related symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Biospecimen
Blood, plasma, and tissue (optional)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Gross
University of Southern California
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
February 24, 2015
Study Start
December 23, 2014
Primary Completion
June 8, 2016
Study Completion
June 8, 2016
Last Updated
April 17, 2017
Record last verified: 2017-04