Abiraterone + Prednisone for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Abiraterone, Prednisone

Must not be taking: Azole drugs, Flutamide

Disqualifiers: Uncontrolled hypertension, Severe hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 years

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Richard Lee, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. Participants must have a confirmed diagnosis, be able to swallow tablets, agree to fast before taking the study drug, use effective birth control, and have a life expectancy of over 6 months. They should not have severe symptoms from their cancer or liver metastases.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through lab tests.

My cancer progressed after stopping hormone therapy.

Willing to use a method of birth control with adequate barrier protection

Exclusion Criteria

I do not have any infections or conditions that prevent me from using steroids.

I have not taken bicalutamide or nilutamide in the last 6 weeks.

My prostate cancer is of the small cell type.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive abiraterone acetate and prednisone, with regular clinic visits for assessments and monitoring

2 years

3 visits in the first 2 months, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

End of Study Treatment Visit

Final assessments and tests are conducted 15-28 days after treatment discontinuation

1 visit (in-person)

Treatment Details

Interventions

• Abiraterone Acetate
• Prednisone

Trial Overview The study tests Abiraterone acetate combined with Prednisone in patients with metastatic castration-resistant prostate cancer (CRPC). It aims to evaluate how circulating tumor cells (CTCs) in blood can indicate the tumor's response to this treatment without needing a biopsy.

Participant Groups

Group I: Abiraterone acetate with Prednisone Experimental Treatment 2 Interventions

1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic high-risk castration-sensitive prostate cancer

Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+