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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/26/2018
Start Date:June 14, 2016
End Date:June 14, 2021
Contact:Cheryl Kefauver, RN
Email:Cheryl.Kefauver@med.usc.edu
Phone:323-865-0459

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Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer

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.

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.

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
We found this trial at
3
sites
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Jacek Pinski, MD
Phone: 323-865-0459
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
Principal Investigator: Jacek Pinski, MD
Phone: 323-865-0459
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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Pasadena, California 91105
Principal Investigator: Jacek Pinski, MD
Phone: 323-865-0459
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