Abiraterone Acetate for Castrate Resistant Prostate Cancer
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests
(such as laboratory or radiology tests) in patients who receive either standard cancer
treatments or new treatments that have been well-tested in many patients on other trials.
It is often difficult to determine how prostate cancer is going to behave when a new
treatment is started. Physicians have no way to predict how a patient's tumor will respond to
treatment. Although scientists have learned about changes that happen in tumors due to
treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to
remove a small piece of tissue) is needed.
This study will evaluate a method to detect tumor cells that are circulating in the blood
without getting a biopsy. It is known that tumors shed a small number of cells into the blood
stream every day. These are called circulating tumor cells or CTCs. Some early studies
indicate the amount and type of CTCs in the blood can help determine the status of the tumor
itself and the way it is responding to treatment. In this study, the investigators will
examine protein levels in CTCs from patients' blood at different times before and after drug
treatment to determine if they correlate with response to the drug. The new test will not
affect whether subjects continue on the study drug.
Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic
CRPC. It blocks the remaining or residual male hormones in the body that may be helping
prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with metastatic
CRPC who have not yet received docetaxel chemotherapy.
Abiraterone acetate has been used by a large number of participants in previous clinical
trials. In most of these trials, participants with CRPC have been given abiraterone acetate
with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid.
Prednisone has been approved in the US, Canada, and Europe for various disorders and
diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of
prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone
together with abiraterone acetate will be given in this study in order to reduce or eliminate
some side effects. Investigators will use patients' blood samples to study the genes (also
called DNA) and their products (RNA and proteins) found in CTCs.