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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in DHEA-S Levels Among Participants at 4 Weeks

Secondary outcome measures

Body Weight Changes

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,001 Previous Clinical Trials

817,680 Total Patients Enrolled

20 Trials studying Prostate Cancer

8,233 Patients Enrolled for Prostate Cancer

Russell Szmulewitz, MDPrincipal InvestigatorUniversity of Chicago

2 Previous Clinical Trials

114 Total Patients Enrolled

2 Trials studying Prostate Cancer

114 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants for this trial?

"Affirmative. Clinicaltrials.gov attests that this trial, initially posted on June 1st 2025, is actively searching for participants to enrol in the study. 50 patients must be recruited across a single medical centre."

Answered by AI

Is this research actively recruiting participants?

"Affirmative. As per the data on clinicaltrials.gov, this current trial is searching for participants which was first posted on June 1st 2025 and recently updated on August 28th 2023. 50 patients are required to be enrolled from a single site."

Answered by AI

To what degree might Group 1: Dose Regimen 1 pose a hazard to test subjects?

"The safety of Group 1: Dose Regimen 1 has been assessed as a score of 1 because this is an early-stage trial. Consequently, there is only limited evidence regarding its efficacy and safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.

2023. "Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276492.

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