NCT02366494

Micro RNAs to Predict Response to Androgen Deprivation Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Male
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Bicalutamide	ANDROGEN BLOCKADE
DRUG	Leuprolide	ANDROGEN BLOCKADE
DRUG	Goserelin	ANDROGEN BLOCKADE
DRUG	Triptorelin	ANDROGEN BLOCKADE
DRUG	Docetaxel	Chemo hormonal therapy
DRUG	Abiraterone	Chemo hormonal therapy
DRUG	Apalutamide	Nonsteroidal antiandrogen medication
DRUG	Enzalutamide	Nonsteroidal antiandrogen medication

Timeline

• Start date: 2015-04-29
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2015-02-19
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study