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.


Study is Available At:


Original ID:

23842


NCT ID:

NCT02366494


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Male


Minimum Age:

21 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical College of Wisconsin


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Deepak Kilari, MD
Principal Investigator
The Medical College of Wisconsin
Primary Contact:Cancer Center Clincial Trials Office
414-805-8900
cccto@mcw.edu
Backup Contact:Deepak Kilari, MD
414-805-4600
dkilari@mcw.edu

Study Dates

Start Date:March 2015
Completion Date:February 2022
Completion Type:Anticipated
Primary Completion Date:February 2021
Primary Completion Type:Anticipated
Verification Date:December 2018
Last Changed Date:December 3, 2018
First Received Date:February 12, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 c
Outcome Type:Secondary Outcome
Measure:Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.
Time Frame:5 years
Safety Issues:False
Description:Selected RNAs, identified through the outcome 1 will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results.

Study Interventions

Intervention Type:Drug
Name:Bicalutamide
Description:ANDROGEN BLOCKADE
Arm Name:Androgen blockade
Other Name:Casodex
Intervention Type:Drug
Name:Leuprolide
Description:ANDROGEN BLOCKADE
Arm Name:Androgen blockade
Other Name:Lupron
Intervention Type:Drug
Name:Goserelin
Description:ANDROGEN BLOCKADE
Arm Name:Androgen blockade
Other Name:Zoladex
Intervention Type:Drug
Name:Triptorelin
Description:ANDROGEN BLOCKADE
Arm Name:Androgen blockade
Other Name:Trelstar
Intervention Type:Drug
Name:Docetaxel
Description:Chemo hormonal therapy
Arm Name:Chemo Hormonal therapy
Other Name:Taxotere

Study Arms

Study Arm Type:Other
Arm Name:Chemo Hormonal therapy
Description:Trelstar IM injection with Docetaxel (Taxorere) 75mg/m2 every 3 weeks for 10 cycles.
Study Arm Type:Other
Arm Name:Androgen blockade
Description:Androgen DeprivationTherapy or Complete Androgen Blockade

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical College of Wisconsin

Samples and Retentions

Sample Retention:Samples With DNA
Description: 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).
Study Population: Men with systemic disease ( with biochemical relpase or metastaic disease)
Sample Method:Probability Sample

Study References

Reference Type:Results Reference
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.
PMID:4625049
Reference Type:Results Reference
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.
PMID:18309951
Reference Type:Reference
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.
PMID:17135641

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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