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Micro RNAs to Predict Response to Androgen Deprivation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02366494
Recruitment Status : Active, not recruiting
First Posted : February 19, 2015
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Deepak Kilari, Medical College of Wisconsin

Brief Summary:
Identify exosomal micro RNA that predict responses to ADT

Condition or disease Intervention/treatment
Prostate Cancer Drug: Bicalutamide Drug: Leuprolide Drug: Goserelin Drug: Triptorelin Drug: Docetaxel Drug: Abiraterone Drug: Apalutamide Drug: Enzalutamide

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.

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Study Type : Observational
Estimated 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 : April 29, 2015
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Androgen blockade
Androgen DeprivationTherapy or Complete Androgen Blockade
Drug: Bicalutamide
ANDROGEN BLOCKADE
Other Name: Casodex

Drug: Leuprolide
ANDROGEN BLOCKADE
Other Name: Lupron

Drug: Goserelin
ANDROGEN BLOCKADE
Other Name: Zoladex

Drug: Triptorelin
ANDROGEN BLOCKADE
Other Name: Trelstar

Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Drug: Bicalutamide
ANDROGEN BLOCKADE
Other Name: Casodex

Drug: Leuprolide
ANDROGEN BLOCKADE
Other Name: Lupron

Drug: Goserelin
ANDROGEN BLOCKADE
Other Name: Zoladex

Drug: Triptorelin
ANDROGEN BLOCKADE
Other Name: Trelstar

Drug: Docetaxel
Chemo hormonal therapy
Other Name: Taxotere

Drug: Abiraterone
Chemo hormonal therapy
Other Name: Zytiga

Drug: Apalutamide
Nonsteroidal antiandrogen medication
Other Name: Erleada

Drug: Enzalutamide
Nonsteroidal antiandrogen medication
Other Name: Xtandi




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood collection at pre treatment (at enrollment), 3 months post treatment, and at the time of disease progression (or at 2 years post treatment).


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with systemic disease ( with biochemical relpase or metastaic disease)
Criteria

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.

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): NCT02366494


Locations
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United States, Wisconsin
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Deepak Kilari, MD The Medical College of Wisconsin
Publications of Results:
Other Publications:
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Responsible Party: Deepak Kilari, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02366494    
Other Study ID Numbers: 23842
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Medical College of Wisconsin:
prostate cancer
treatment response
androgen deprivation therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Docetaxel
Leuprolide
Goserelin
Bicalutamide
Triptorelin Pamoate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Contraceptive Agents, Hormonal