Micro RNAs to Predict Response to Androgen Deprivation Therapy

April 11, 2024 updated by: Deepak Kilari, Medical College of Wisconsin

Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients

Identify exosomal micro RNA that predict responses to ADT

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

  2. 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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men with systemic disease ( with biochemical relpase or metastaic disease)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
Time Frame: 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.
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2015

Primary Completion (Actual)

May 11, 2021

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimated)

February 19, 2015

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Bicalutamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe