Metastatic Prostate Carcinoma Clinical Trial
Official title:
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.
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.
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