Micro RNAs to Predict Response to Androgen Deprivation Therapy

Medical College of Wisconsin

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Bicalutamide; Drug: Apalutamide; Drug: Triptorelin; Drug: Goserelin; Drug: Abiraterone; Drug: Enzalutamide; Drug: Leuprolide; Drug: Docetaxel

Study type: Observational

Funder types: Other

Identifiers

NCT02366494

23842

Details and patient eligibility

About

Identify exosomal micro RNA that predict responses to ADT

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Androgen blockade

Description:

Androgen DeprivationTherapy or Complete Androgen Blockade

Treatment:

Drug: Leuprolide

Drug: Goserelin

Drug: Triptorelin

Drug: Bicalutamide

Hormonal Therapy and Chemotherapy

Description:

Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)

Treatment:

Drug: Docetaxel

Drug: Enzalutamide

Drug: Leuprolide

Drug: Abiraterone

Drug: Goserelin

Drug: Triptorelin

Drug: Apalutamide

Drug: Bicalutamide