Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 3:50 PM
Study NCT ID:
NCT05276492
Status:
TERMINATED
Last Update Posted:
2025-10-03
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by PI due to not meeting primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: