- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853097
Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients
Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90033
- Los Angeles County-USC Medical Center
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Pasadena, California, United States, 91105
- Keck Medical Center of USC Pasadena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one of the following 5 groups:
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 who receive combined ADT with docetaxel for hormone-naive metastatic prostate cancer
- Patients on intermittent ADT
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Correlative studies
Undergo blood collection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in AR-V7 presence
Time Frame: Baseline to 3 years
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Each of the 4 longitudinal cohorts will be analyzed separately (at least initially).
Kaplan-Meier-like curves (likely adjusted for interval censoring) will be used to display the development of AR-V7 positivity.
To complement the analysis of Cohort A, an exact logistic regression analysis will be used with the data from Cohort X with AR-V7 splice variant positivity as the dependent variable and time since start of ADT as the independent variable.
Logistic regression will be used to assess the association between AR-V7 status at start of treatment and overall response to treatment.
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Baseline to 3 years
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Expression level of AR-V7 in serum cfRNA assessed by quantitative RT-PCR
Time Frame: Up to 3 years
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Detectable AR-V7 will be associated with a shortened duration of treatment benefit (ADT, abiraterone, enzalutamide, docetaxel).
Each of the 4 longitudinal cohorts will be analyzed separately (at least initially).
A regression analysis based on the Cox proportional hazards model (if proportional hazards holds) will be used to assess the association between AR-V7 and time to new treatment.
Initially, only the baseline AR-V7 status will be used.
Next, AR-V7 will be included as a time dependent covariate; the model used may be modified to accommodate competing risks (if too many switch treatment p
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Up to 3 years
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Time to start of another treatment
Time Frame: Time from start of treatment until the time that the patient begins another therapy, assessed up to 3 years
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Time from start of treatment until the time that the patient begins another therapy, assessed up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression levels of AR-Vs (other than AR-V7) in serum cfRNA assessed by quantitative RT-PCR
Time Frame: Up to 3 years
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Up to 3 years
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Tumor response as measured by Prostate Cancer Working Group
Time Frame: Up to 3 years
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Up to 3 years
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4P-15-4 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2016-00958 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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