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Anti-tumor antibiotic

Abiraterone Dosing for Prostate Cancer

Phase 1

Waitlist Available

Led By Russell Szmulewitz, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Have never received prior abiraterone or other androgen receptor modulators, including enzalutamide, apalutamide, or darolutamide

Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug

Must not have

Inability to swallow capsules or known gastrointestinal malabsorption

Serious heart issues/congestive heart failure as assessed by New York Heart Association's definition of class II, class III, or IV congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Approved for 30 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying the best dose of a prostate cancer drug, abiraterone acetate, for up to 12 weeks. Participants will decide how long to stay on the drug after. #medicine

Who is the study for?

Men with confirmed prostate cancer who are starting abiraterone and prednisone treatment for the first time can join. They must have not used similar drugs before, have a specific baseline hormone level, normal liver function, and be in good enough health to perform daily activities. Those with uncontrolled blood pressure, low potassium levels, serious heart conditions or infections, or taking certain other medications cannot participate.

What is being tested?

The study is testing the lowest effective dose of abiraterone acetate (500 mg) taken orally by men with prostate cancer over a period of 12 weeks. Participants will also take prednisone and keep a drug diary while eating low-fat meals. The focus is on finding the minimum dose that still provides benefits.

What are the potential side effects?

Abiraterone may cause side effects like high blood pressure, fluid retention leading to swelling in legs or feet, fatigue, liver problems including hepatitis or jaundice (yellowing skin), urinary tract infection symptoms such as burning sensation during urination.

Eligibility Criteria

Inclusion Criteria

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

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I have never taken abiraterone or similar prostate cancer drugs.

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I haven't had any radiotherapy or radionuclide treatments in the last 28 days.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have prostate cancer confirmed by a lab test and plan to start abiraterone acetate.

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I haven't had cancer treatment, except for hormone therapy, in the last 28 days.

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My liver function tests are within normal range.

Exclusion Criteria

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

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I cannot swallow pills or have a condition that affects how my body absorbs food.

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I have serious heart issues classified by the NYHA.

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I do not have serious infections or illnesses that are not under control.

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I am not on drugs that strongly affect how my body processes certain medications.

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I haven't taken specific hormonal therapies or steroids affecting PSA levels in the last 4 weeks.

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My blood pressure remains high despite taking more than two medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in DHEA-S Levels Among Participants at 4 Weeks

Secondary study objectives

Body Weight Changes

Rate of Adverse Events Reported Among Participants in Different Abiraterone Dosing Regimen Groups

Awards & Highlights

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: Dose Regimen 4Experimental Treatment4 Interventions

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

Group II: Group 3: Dose Regimen 3Experimental Treatment4 Interventions

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 and day 4 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

Group III: Group 2: Dose Regimen 2Experimental Treatment4 Interventions

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1, day 3, day 5 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

Group IV: Group 1: Dose Regimen 1Experimental Treatment4 Interventions

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal every other day. You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

FDA approved

Low-fat meal

2017

N/A

~20

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