Micro RNAs to Predict Response to Androgen Deprivation Therapy

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02366494
Collaborator
(none)
60
1
121.1
0.5

Study Details

Study Description

Brief Summary

Identify exosomal micro RNA that predict responses to ADT

Detailed Description

  1. Identify novel exosomal RNA signatures at pretreatment that predict response to ADT.

The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients.

The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment.

  1. Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.

Secondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
Actual Study Start Date :
Apr 29, 2015
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Androgen blockade

Androgen DeprivationTherapy or Complete Androgen Blockade

Drug: Bicalutamide
ANDROGEN BLOCKADE
Other Names:
  • Casodex
  • Drug: Leuprolide
    ANDROGEN BLOCKADE
    Other Names:
  • Lupron
  • Drug: Goserelin
    ANDROGEN BLOCKADE
    Other Names:
  • Zoladex
  • Drug: Triptorelin
    ANDROGEN BLOCKADE
    Other Names:
  • Trelstar
  • Hormonal Therapy and Chemotherapy

    Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)

    Drug: Bicalutamide
    ANDROGEN BLOCKADE
    Other Names:
  • Casodex
  • Drug: Leuprolide
    ANDROGEN BLOCKADE
    Other Names:
  • Lupron
  • Drug: Goserelin
    ANDROGEN BLOCKADE
    Other Names:
  • Zoladex
  • Drug: Triptorelin
    ANDROGEN BLOCKADE
    Other Names:
  • Trelstar
  • Drug: Docetaxel
    Chemo hormonal therapy
    Other Names:
  • Taxotere
  • Drug: Abiraterone
    Chemo hormonal therapy
    Other Names:
  • Zytiga
  • Drug: Apalutamide
    Nonsteroidal antiandrogen medication
    Other Names:
  • Erleada
  • Drug: Enzalutamide
    Nonsteroidal antiandrogen medication
    Other Names:
  • Xtandi
  • Outcome Measures

    Primary Outcome Measures

    1. Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment. [Up to two years]

      Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically proven prostate cancer.

    • Testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.

    • History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.

    • CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.

    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

    • Age ≥ 18.

    • Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).

    Exclusion Criteria:
    • Received hormonal therapy less than 6 months prior to registration.

    • History of active secondary malignancy.

    • Decline hormone therapy for prostate cancer.

    • Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Froedtert Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    • Principal Investigator: Deepak Kilari, MD, The Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Deepak Kilari, Associate Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT02366494
    Other Study ID Numbers:
    • 23842
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Deepak Kilari, Associate Professor, Medical College of Wisconsin
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022