Micro RNAs to Predict Response to Androgen Deprivation Therapy

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.

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.