Micro RNAs to Predict Response to Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02366494
• Other study ID #: 23842
• Status: Active, not recruiting
• Start date: April 29, 2015
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Identify exosomal micro RNA that predict responses to ADT

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 2025
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide
ANDROGEN BLOCKADE
• Leuprolide
ANDROGEN BLOCKADE
• Goserelin
ANDROGEN BLOCKADE
• Triptorelin
ANDROGEN BLOCKADE
• Docetaxel
Chemo hormonal therapy
• Abiraterone
Chemo hormonal therapy
• Apalutamide
Nonsteroidal antiandrogen medication
• Enzalutamide
Nonsteroidal antiandrogen medication

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 Worki — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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