Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer
NCT ID: NCT02370355
Last Updated: 2017-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
24 participants
OBSERVATIONAL
2014-12-23
2016-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole
NCT01275651
Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583
NCT00898833
Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer
NCT02723526
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
NCT00967954
Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2
NCT01160705
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi).
II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.
GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG).
GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I (retrospective analysis)
Previously collected plasma samples are analyzed for ctDNA via PCR and NSG.
Laboratory Biomarker Analysis
Correlative studies
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.
Cytology Specimen Collection Procedure
Undergo collection of blood samples
Laboratory Biomarker Analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cytology Specimen Collection Procedure
Undergo collection of blood samples
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
19 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mitchell Gross
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2014-02682
Identifier Type: REGISTRY
Identifier Source: secondary_id
HS-14-00861
Identifier Type: -
Identifier Source: secondary_id
4P-14-6
Identifier Type: OTHER
Identifier Source: secondary_id
4P-14-6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.