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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02682 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HS-14-00861 | |||
| 4P-14-6 | Other Identifier | USC Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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Sponsor decided not to pursue study
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (retrospective analysis) | Previously collected plasma samples are analyzed for ctDNA via PCR and NSG. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo collection of blood samples |
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| 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 |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Gross | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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Blood, plasma, and tissue (optional)
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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