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

University of Southern California

Status: Terminated

Conditions: Hormone-Resistant Prostate Cancer; Prostate Adenocarcinoma; Metastatic Prostate Carcinoma

Treatments: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02853097

NCI-2016-00958 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

4P-15-4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 1 patient group

Ancillary-Correlative (blood collection)

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure