Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients
NCT ID: NCT02853097
Last Updated: 2021-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
7 participants
OBSERVATIONAL
2016-06-14
2020-09-27
Brief Summary
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Detailed Description
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I. To document the appearance of androgen receptor isoform splice variant 7 (AR-V7) expression over the course of therapy in castration-resistant prostate cancer (CRPC).
II. To determine whether detectable AR-V7 is associated with a shortened duration of treatment benefit of abiraterone or enzalutamide.
SECONDARY OBJECTIVES:
I. To determine how the presence and expression level of AR-V7 impacts response to docetaxel.
II. To determine at what point AR-V7 arises during androgen deprivation therapy (ADT) and how its presence and expression corresponds to castration resistance.
TERTIARY OBJECTIVES:
I. To determine if androgen receptor isoform splice variants (AR-Vs) other than AR-V7 play a role in resistance and / or response to the therapies explored in this study.
II. To determine if, in patients who do not express mutations in androgen receptor (AR), other genetic alterations are associated with treatment outcomes to the therapies explored in this study.
OUTLINE:
Patients undergo blood collection every 4-12 weeks during ADT, abiraterone and / or enzalutamide and docetaxel. Patients switched from ADT to either abiraterone or enzalutamide during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cell-free ribonucleic acid (cfRNA), cell-free deoxyribonucleic acid (cfDNA), AR-V7, and other AR-Vs via quantitative reverse transcriptase-polymerase chain reaction (RT-PCR).
After completion of study, patients are followed up for 3 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ancillary-Correlative (blood collection)
Patients undergo blood collection every 4-12 weeks during ADT, abiraterone, enzalutamide, or docetaxel treatment. Patients switched from ADT to either abiraterone or enzalutamide during the study will undergo phlebotomy every 6-12 weeks. Samples are analyzed for cfRNA, and cfDNA, AR-V7, and other AR-Vs via quantitative RT-PCR.
Cytology Specimen Collection Procedure
Undergo blood collection
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Cytology Specimen Collection Procedure
Undergo blood collection
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently receiving ADT (previously untreated for metastatic disease)
* These patients will be grouped into 3 cohorts: having received ADT for 3-6 months; for 1-2 years; and for \> 3 years
* Scheduled to begin treatment with ADT (previously untreated for metastatic disease)
* Scheduled to begin treatment with enzalutamide (castration resistant / has received ADT / may have received abiraterone)
* Scheduled to begin treatment with abiraterone (castration resistant / has received ADT / may have received enzalutamide)
* Scheduled to begin treatment with docetaxel (castration resistant / has received ADT / has received enzalutamide and/or abiraterone)
* Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease
* Ability and willingness to provide written and informed consent
Exclusion Criteria
* Patients on intermittent ADT
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Jacek Pinski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Countries
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Other Identifiers
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NCI-2016-00958
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-15-4
Identifier Type: OTHER
Identifier Source: secondary_id
4P-15-4
Identifier Type: -
Identifier Source: org_study_id
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