Micro RNAs to Predict Response to Androgen Deprivation Therapy

Study Overview
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Brief Summary
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Identify exosomal micro RNA that predict responses to ADT

Detailed Description
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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. 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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Bicalutamide
* Drug: Leuprolide
* Drug: Goserelin
* Drug: Triptorelin
* Drug: Docetaxel
* Drug: Abiraterone
* Drug: Apalutamide
* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Androgen blockade<br>Androgen DeprivationTherapy or Complete Androgen Blockade | Drug: Bicalutamide<br>* ANDROGEN BLOCKADE<br>* Other names: Casodex;Drug: Leuprolide<br>* ANDROGEN BLOCKADE<br>* Other names: Lupron;Drug: Goserelin<br>* ANDROGEN BLOCKADE<br>* Other names: Zoladex;Drug: Triptorelin<br>* ANDROGEN BLOCKADE<br>* Other names: Trelstar;|
| Hormonal Therapy and Chemotherapy<br>Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel) | Drug: Bicalutamide<br>* ANDROGEN BLOCKADE<br>* Other names: Casodex;Drug: Leuprolide<br>* ANDROGEN BLOCKADE<br>* Other names: Lupron;Drug: Goserelin<br>* ANDROGEN BLOCKADE<br>* Other names: Zoladex;Drug: Triptorelin<br>* ANDROGEN BLOCKADE<br>* Other names: Trelstar;Drug: Docetaxel<br>* Chemo hormonal therapy<br>* Other names: Taxotere;Drug: Abiraterone<br>* Chemo hormonal therapy<br>* Other names: Zytiga;Drug: Apalutamide<br>* Nonsteroidal antiandrogen medication<br>* Other names: Erleada;Drug: Enzalutamide<br>* Nonsteroidal antiandrogen medication<br>* Other names: Xtandi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, treatment response, androgen deprivation therapy