Status:
SUSPENDED
Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)
Lead Sponsor:
Exosome Diagnostics, Inc.
Collaborating Sponsors:
Yale University
Conditions:
Metastatic Castrate Resistant Prostate Cancer
Eligibility:
MALE
18+ years
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 enza...
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. ...
Eligibility Criteria
Inclusion
- 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/dL with continued 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03236688
Start Date
February 1 2016
End Date
December 1 2024
Last Update
October 6 2022
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520