Trial Summary
What is the purpose of this trial?Doctors leading this study plan to collect new information about the lowest effective dose of abiraterone acetate in study participants with prostate cancer who are taking abiraterone in combination with prednisone for the first time. The duration of this study will be about 3 months (12 weeks). How long you stay on abiraterone, and at what dose after completion of the 12 weeks of study drug administration, will be up to you and your treating physician.
Eligibility Criteria
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.Inclusion Criteria
I am taking Denosumab or Zoledronic acid.
I have never taken abiraterone or similar prostate cancer drugs.
I haven't had any radiotherapy or radionuclide treatments in the last 28 days.
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Exclusion Criteria
I cannot swallow pills or have a condition that affects how my body absorbs food.
Serum K+ < 3.5 mmoL/L. Patients with a K+ < 3.5 mmoL/L are required to have a documented subsequent K+ >3.5 prior to enrollment to be eligible
Active psychiatric illness/social situations that would limit compliance with protocol requirements
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Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago Medicine Comprehensive Cancer CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor