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Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT02853097
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in blood from patients with prostate cancer that does not respond to hormone therapy and has spread to other places in the body. Studying samples of blood from patients with prostate cancer may help doctors to learn more about the changes that occur in tumor cells over time and how they become resistant to anti-cancer drugs.

Condition or disease Intervention/treatment
Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Adenocarcinoma Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Primary Completion Date : June 14, 2020
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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 ]

Secondary Outcome Measures :
  1. Expression levels of AR-Vs (other than AR-V7) in serum cfRNA assessed by quantitative RT-PCR [ Time Frame: Up to 3 years ]
  2. Tumor response as measured by Prostate Cancer Working Group [ Time Frame: Up to 3 years ]

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer patients at various points throughout androgen deprivation therapy and at the initiation of androgen deprivation therapy, enzalutamide, abiraterone and docetaxel with either computed tomography measurable or evaluable disease or arising prostate specific antigen disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Cheryl Kefauver, RN 323-865-0459 Cheryl.Kefauver@med.usc.edu

Locations
United States, California
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Cheryl Kefauve, RN    323-865-0459    Cheryl.Kefauver@med.usc.edu   
Principal Investigator: Jacek Pinski, MD         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Cheryl Kefauver, RN    323-865-0459    Cheryl.Kefauver@med.usc.edu   
Principal Investigator: Jacek Pinski, MD         
Keck Medical Center of USC Pasadena Recruiting
Pasadena, California, United States, 91105
Contact: Cheryl Kefauver, RN    323-865-0459    Cheryl.Kefauver@med.usc.edu   
Principal Investigator: Jacek Pinski, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jacek Pinski, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02853097     History of Changes
Other Study ID Numbers: 4P-15-4
NCI-2016-00958 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4P-15-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type