NCT05276492

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

Abiraterone Dose De-Escalation Study: A Prospective Study Evaluating Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Therefore, this study will evaluate if alternative dosing strategies with 500 mg pills may be equally effective as taking abiraterone 1000 mg daily. This study will specifically assess whether taking 500 mg of abiraterone every other day with a low-fat meal, or 500 mg with a low-fat meal at less frequent intervals (fewer times per week), is equally effective in treating prostate cancer as the 1000 mg/day dose.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Neoplasm
• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Abiraterone Oral Tablet	Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
DRUG	Prednisone tablet	Prednisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.
OTHER	Drug Dairy/Log	A drug dairy/log that will the study team will give for you to document information about the study drugs and meals you take during the study.
DRUG	Low-fat meal	A low-fat meal that will be taken with abiraterone. If you have questions about what is considered "a low-fat" meal during the study, ask the study doctor or research staff.

Timeline

• Start date: 2023-01-24
• Primary completion: 2024-11-16
• Completion: 2024-11-16
• First posted: 2022-03-11
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study