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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Prostate Carcinoma; Hormone-Resistant Prostate Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (retrospective analysis); Previously collected plasma samples are analyzed for ctDNA via PCR and NSG.	Other: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Cytology Specimen Collection Procedure; Undergo collection of blood samples; Other Names: Cytologic Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mitchell Gross, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2014
• Primary Completion (Actual): June 8, 2016
• Study Completion (Actual): June 8, 2016

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4P-14-6 (Other Identifier: USC Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2014-02682 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HS-14-00861

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No