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Trial record 23 of 1543 for:    Androgens

Micro RNAs to Predict Response to Androgen Deprivation Therapy

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ClinicalTrials.gov Identifier: NCT02366494
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : December 5, 2018
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

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

    We will collect blood samples from patients with systemic disease pretreatment (at enrollment), 3 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.

    We plan to identify exosomal RNAs signatures that change between pre-treatment (at enrollment) and during treatment (at 3 month) and further explore the effect of these changes on disease response. We also plan to compare exosomal RNA levels between patients relapse within the first 2 years versus those in remission at 2 years. Among patients with progression, we 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. We expect to select and validate approximate 5 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 : March 2015
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

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

Chemo Hormonal therapy
Trelstar IM injection with Docetaxel (Taxorere) 75mg/m2 every 3 weeks for 10 cycles.
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




Primary Outcome Measures :
  1. Identify exosomal micro RNAs that predict response to Androgen deprivation therapy( ADT) from peripheral blood of prostate cancer patients with systemic disease. [ Time Frame: 5years ]

    We will first identify two cohorts of patients, patients with intermediate/high risk features at diagnosis status post definitive treatment , now with biochemical relapse and clinical metastatic PC patients with high volume disease

    Subsequently we will collect blood samples from these patients pretreatment (at enrollment), 3 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.



Secondary Outcome Measures :
  1. Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR. [ Time Frame: 5 years ]
    Selected RNAs, identified through the outcome 1 will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results.


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).


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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.
  • 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


Contacts
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Contact: Cancer Center Clincial Trials Office 414-805-8900 cccto@mcw.edu
Contact: Deepak Kilari, MD 414-805-4600 dkilari@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Deepak Kilari, MD    414-805-4600    dkilari@mcw.edu   
Contact: Liang Wang, MD, PhD    414-955-2574    liwang@mcw.edu   
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, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02366494     History of Changes
Other Study ID Numbers: 23842
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Deepak Kilari, Medical College of Wisconsin:
prostate cancer
treatment response
androgen deprivation therapy
Additional relevant MeSH terms:
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Androgens
Androgen Antagonists
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Docetaxel
Methyltestosterone
Leuprolide
Goserelin
Bicalutamide
Triptorelin Pamoate
Estrogens, Conjugated (USP)
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Protective Agents
Vitamins
Micronutrients
Nutrients