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Androgen Biosynthesis Inhibitor

Abiraterone + Prednisone for Prostate Cancer

N/A
Waitlist Available
Led By Richard Lee, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed adenocarcinoma of the prostate
Able to swallow the study drug whole as a tablet
Must not have
Clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart disease
Active infection or other medical condition that would make corticosteroid use contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group

Summary

"This trial is testing a new method to detect circulating tumor cells in the blood of prostate cancer patients without needing a biopsy. The study will analyze protein levels in these cells to see if they can predict how

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Abiraterone may cause side effects like high blood pressure, fluid retention, low potassium levels, muscle discomfort, and liver function changes. Prednisone might lead to increased appetite, weight gain, insomnia or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer diagnosis was confirmed through lab tests.
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I can swallow pills without any difficulty.
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My cancer progressed after stopping hormone therapy.
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My prostate cancer symptoms are mild or non-existent.
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I am willing to take abiraterone without eating.
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My cancer has spread to my bones or other areas, but not my liver or internal organs.
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I have undergone treatment to lower my testosterone levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack or serious heart disease in the last 6 months.
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I do not have any infections or conditions that prevent me from using steroids.
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My blood pressure is not controlled by medication.
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My diabetes is not well-managed.
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My prostate cancer is of the small cell type.
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My cancer has spread to my liver, another organ, or brain.
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I have severe liver problems.
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I have active hepatitis or chronic liver disease.
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I have been treated with an azole medication before.
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I need long-term corticosteroids for a condition I already have.
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I am allergic to abiraterone acetate, prednisone, or their ingredients.
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I have had issues with my pituitary or adrenal glands.
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I have received chemotherapy or biological therapy for prostate cancer after it became resistant to hormonal treatment.
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I have been treated with ketoconazole for my prostate cancer for more than a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of AR signaling in CTCs and correlation with response
Secondary study objectives
Change in number and proliferative fraction of CTCs with abiraterone treatment

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abiraterone acetate with PrednisoneExperimental Treatment2 Interventions
1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,271 Total Patients Enrolled
35 Trials studying Prostate Cancer
3,638 Patients Enrolled for Prostate Cancer
Richard Lee, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
500 Total Patients Enrolled
~3 spots leftby Nov 2025
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