Clinical trial NCT02366494: Micro RNAs to Predict Response to Androgen Deprivation Therapy
Official title: Utility of Exosomal MicroRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
treatment response
androgen deprivation therapy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 42
Sex: MALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with systemic disease ( with biochemical relpase or metastaic disease)

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

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.

Eligibility 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.

Primary outcomes:
measure: Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
timeFrame: Up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: The Medical College of Wisconsin
name: Deepak Kilari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.
citation: Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.
citation: Taplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589.