Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer

Metastatic Prostate Carcinoma Clinical Trial

Official title:

Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02370355
• Other study ID #: 4P-14-6
• Secondary ID: NCI-2014-02682HS
• Status: Terminated
• Phase: N/A
• First received: February 17, 2015
• Last updated: April 13, 2017
• Start date: December 23, 2014
• Est. completion date: June 8, 2016

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: June 8, 2016
• Est. primary completion date: June 8, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo collection of blood samples
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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