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Antiandrogen

Abiraterone + Prednisone for Prostate Cancer (APRE Trial)

Phase 2

Recruiting

Led By Martha Mims, MD, PhD

Research Sponsored by Martha Mims

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have had no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone. The start date of medical castration is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not an oral antiandrogen. If the method of castration was luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonist and add Abiraterone + Prednisone treatment. If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to Abiraterone + Prednisone treatment. There is no limit on how many days a patient may have been on an antiandrogen (e.g. bicalutamide, flutamide) or a five alpha reductase inhibitor (e.g. finasteride or dutasteride) prior to going on study and no washout is required.

All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic disease as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy (ADT). NOTE: ADT does not include treatment with anti-androgens such as bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or dutasteride.

Must not have

Patients must not be known to have hypersensitivity to abiraterone or to LHRH agonist.

Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration. (Note: Androgen deprivation therapy may prolong the QT/QTc interval. Patients with congenital long AT syndrome, congestive heart failure, frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT interval may be at increased risk.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment start until nadir, or up to 7 months after start of adt if no nadir

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well standard prostate cancer treatments work in different ethnic groups.

Who is the study for?

Men with metastatic hormone naive prostate cancer who have not received certain prior treatments like ketoconazole or chemotherapy for metastasis. They must be over 18, have adequate organ function, and a Zubrod performance status of 0-2 (3 if due to bone pain). Prior surgery is okay after recovery, and they can't have severe heart issues or known brain metastases.

What is being tested?

The study examines the effectiveness of standard care treatment with abiraterone acetate and prednisone in men with prostate cancer across different races/ethnicities. Participants will be followed for up to 10 years to see how well these treatments work.

What are the potential side effects?

Abiraterone may cause high blood pressure, fluid retention, liver function changes, joint swelling/discomfort; Prednisone might lead to weight gain, mood swings, increased blood sugar levels among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I started hormone therapy for prostate cancer less than 42 days ago and am willing to switch or continue treatment as required.

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I have prostate cancer that has spread, and I haven't started hormone therapy yet.

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I am 18 years old or older.

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My liver is functioning well according to recent tests.

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My blood tests meet the required levels for white blood cells, neutrophils, hemoglobin, and platelets.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to abiraterone or LHRH agonists.

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I don't have severe heart failure or recent serious heart problems.

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I do not have a history of adrenal insufficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment start until 7 months after start of adt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment start until 7 months after start of adt

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment start until 7 months after start of adt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA Response Rate

Secondary study objectives

Depth of PSA Response

Frequency of Potentially Deleterious Polymorphisms

Progression Free Survival

+3 more

Awards & Highlights

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 + prednisoneExperimental Treatment2 Interventions

All subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2500