Prostate Cancer Clinical Trial

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

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)

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
Clinical or radiographic evidence of metastatic disease.
Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.

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>androgen deprivation therapy.

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

Exclusion Criteria:

Receiving or intend to receive concurrent chemotherapy
Hepatitis (all types) in patient's medical record
HIV documented in patient's medical record
History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT03236688

Recruitment Status:

Suspended

Sponsor:

Exosome Diagnostics, Inc.

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There is 1 Location for this study

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Yale University School of Medicine
New Haven Connecticut, 06520, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT03236688

Recruitment Status:

Suspended

Sponsor:


Exosome Diagnostics, Inc.

How clear is this clinincal trial information?

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