Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02853097|
Recruitment Status : Terminated (Slow accrual)
First Posted : August 2, 2016
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment|
|Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Adenocarcinoma||Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis|
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.
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.
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.
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 :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer|
|Actual Study Start Date :||June 14, 2016|
|Actual Primary Completion Date :||September 27, 2020|
|Actual Study Completion Date :||September 27, 2020|
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.
Other: Cytology Specimen Collection Procedure
Undergo blood collection
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
- Change in AR-V7 presence [ Time Frame: Baseline to 3 years ]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.
- Expression level of AR-V7 in serum cfRNA assessed by quantitative RT-PCR [ Time Frame: Up to 3 years ]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
- 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 ]
- Expression levels of AR-Vs (other than AR-V7) in serum cfRNA assessed by quantitative RT-PCR [ Time Frame: Up to 3 years ]
- Tumor response as measured by Prostate Cancer Working Group [ Time Frame: Up to 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853097
|United States, California|
|Los Angeles County-USC Medical Center|
|Los Angeles, California, United States, 90033|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Keck Medical Center of USC Pasadena|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Jacek Pinski, MD||University of Southern California|