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Trial record 43 of 127 for:    exosomes

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

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ClinicalTrials.gov Identifier: NCT03236688
Recruitment Status : Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

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)

Condition or disease
Metastatic Castrate Resistant Prostate Cancer

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
MCRPC
Metastatic Castrate Resistant Prostate Cancer (MCRPC) Patients



Primary Outcome Measures :
  1. Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 positive patients. [ Time Frame: Two years ]
    The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 10% or less in ARv7 positive patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.


Secondary Outcome Measures :
  1. Detection of ARv7 splice variant in the circulation of MCRPC patients. PSA response rate in ARv7 negative patients. [ Time Frame: Two years ]
    The detection of ARv7 splice variants in samples will be considered both binary: positive or negative/not assessable and level based. ARv7 splice variants from exosomes will be detectable from baseline in 50% of both API; PSA response rates will be 50% or more in ARv7 negative patients. With a sample of 30 patients (as reported in the NEJM study) per cohort would allow the study to have an 85% power to detect a difference of 50 percentage points in PSA response rates, with the use of a two-sided test at an alpha level of 0.1.


Biospecimen Retention:   Samples Without DNA
10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired via standard venipuncture and processed to plasma.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community sample
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236688


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Exosome Diagnostics, Inc.
Yale University
Investigators
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Study Director: Roger Tun Exosome Diagnostics, Inc.

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Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03236688     History of Changes
Other Study ID Numbers: ECT2015-004
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases