Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)

NCT ID: NCT03236688

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2024-12-31

Brief Summary

Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Detailed Description

Primary Objective

-Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Secondary and Exploratory Objectives

• Correlate ARv7 status with PSA response (>/=50% decline in PSA level from baseline, maintained for >/=4 weeks) at any time after the initiation of therapy.
• Comparison of median progression free survival (PFS) and overall survival (OS).
• Determine additional molecular lesions in exoRNA and cfDNA in MCRPC patients post-treatment with androgen pathway inhibitors.
• Correlate other AR-variants (non ARv7) with clinical outcomes including PSA response.

Conditions

Metastatic Castrate Resistant Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MCRPC

Metastatic Castrate Resistant Prostate Cancer (MCRPC) Patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.

2. Clinical or radiographic evidence of metastatic disease.

3. Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.

4. Evidence of disease progression on or following most recent therapy as evidenced by the following:

• Radiographic evidence of disease progression as defined by one or more new bone scan lesions.
• Growth of soft tissue / visceral metastases to greater than one centimeter in longest diameter.
• Progressive disease despite 'castration levels' of serum testosterone (<50ng/dL with continued androgen deprivation therapy.

5. At least two of the following high risk features during screening for rapid disease progression:

• Anemia with a hemoglobin <12.0 g/dL
• Elevated alkaline phosphatase
• High lactate dehydrogenase (LDH)
• Presence of visceral metastasis on imaging
• Presence of clinically significant pain requiring opioid analgesics.
• PSA doubling time under 3 months on most recent therapy
• PSA values obtained 2 or more weeks apart, with last value being 2.0ng/mL or higher.

6. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Receiving or intend to receive concurrent chemotherapy

2. Hepatitis (all types) in patient's medical record

3. HIV documented in patient's medical record

4. History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Exosome Diagnostics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Tun

Role: STUDY_DIRECTOR

Exosome Diagnostics, Inc.

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

ECT2015-004

Identifier Type: -

Identifier Source: org_study_id