Milwaukee, Wisconsin 53226


Purpose:

Identify exosomal micro RNA that predict responses to ADT


Study summary:

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.


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.


NCT ID:

NCT02366494


Primary Contact:

Principal Investigator
Deepak Kilari, MD
The Medical College of Wisconsin

Cancer Center Clincial Trials Office
Phone: 414-805-8900
Email: cccto@mcw.edu


Backup Contact:

Email: dkilari@mcw.edu
Deepak Kilari, MD
Phone: 414-805-4600


Location Contact:

Milwaukee, Wisconsin 53226
United States

Deepak Kilari, MD
Phone: 414-805-4600
Email: dkilari@mcw.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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