Micro RNAs to Predict Response to Androgen Deprivation Therapy

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Triptorelin; Drug: Docetaxel; Drug: Abiraterone; Drug: Apalutamide; Drug: Enzalutamide

• Registration Number: NCT02366494
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-19
• Study Start: 2015-04-29
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Androgen blockade	Leuprolide	Androgen DeprivationTherapy or Complete Androgen Blockade
Androgen blockade	Bicalutamide	Androgen DeprivationTherapy or Complete Androgen Blockade
Androgen blockade	Triptorelin	Androgen DeprivationTherapy or Complete Androgen Blockade
Hormonal Therapy and Chemotherapy	Bicalutamide	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Androgen blockade	Goserelin	Androgen DeprivationTherapy or Complete Androgen Blockade
Hormonal Therapy and Chemotherapy	Leuprolide	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Goserelin	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Triptorelin	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Docetaxel	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Abiraterone	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Apalutamide	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
Hormonal Therapy and Chemotherapy	Enzalutamide	Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)

Primary Outcome Measures

Name	Time	Method
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.	Up to two years	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.

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States