Abiraterone Acetate for Castrate Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01961843|
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : April 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Abiraterone Drug: Prednisone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigator-Initiated, Pilot Translational Study of Circulating Tumor Cells to Identify Predictive Factors of Response to Abiraterone Acetate in Men With Castration-Resistant Prostate Cancer|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Abiraterone acetate with Prednisone
1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day
Abiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis.
Prednisone is a synthetic corticosteroid that is co-administered with abiraterone acetate to offset the hypokalemia and hypertension side effects of abiraterone acetate.
- Assessment of AR signaling in CTCs and correlation with response [ Time Frame: 2 years ]To assess AR signaling in CTCs and correlate with PSA response and/or measurable disease response, if applicable. The investigators have developed a protein-based test to evaluate whether the AR signal is active ("AR-on") or inactive ("AR-off") or indeterminate ("AR-mixed"). The investigators will examine the AR signaling present in CTCs prior to and during abiraterone therapy. By correlating the baseline or post-treatment change in AR signaling with other measures of clinical benefit, the investigators aim to evaluate the use of AR signaling in CTCs to predict response to abiraterone. This may be applicable to other agents that target AR signaling.
- Change in number and proliferative fraction of CTCs with abiraterone treatment [ Time Frame: 2 years ]The investigators will examine the number number and proliferative fraction of CTCs found in the blood of subjects prior to and during abiraterone treatment. Proliferation will be measured by Ki-67 staining. Baseline and post-treatment change in Ki-67 proliferative index will be correlated with other measure of clinical response to abiraterone.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961843
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Richard Lee, MD, PhD||Massachusetts General Hospital|