NCT02370355

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo collection of blood samples
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-12-23
• Primary completion: 2016-06-08
• Completion: 2016-06-08
• First posted: 2015-02-24
• Last updated: 2017-04-17

Locations

1 site across 1 country: United States