Trial Outcomes & Findings for Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT01503229)
NCT ID: NCT01503229
Last Updated: 2021-05-14
Results Overview
Tissue testosterone will be measured in biopsy tissues
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From baseline to week 4
Results posted on
2021-05-14
Participant Flow
Participant milestones
| Measure |
Treatment (Abiraterone Acetate and Prednisone)
Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Abiraterone Acetate: Given orally
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Prednisone: Given orally
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Abiraterone Acetate and Prednisone)
Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Abiraterone Acetate: Given orally
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Prednisone: Given orally
|
|---|---|
|
Overall Study
Withdrew consent
|
1
|
Baseline Characteristics
Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Abiraterone Acetate and Prednisone)
n=29 Participants
Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Abiraterone Acetate: Given orally
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Prednisone: Given orally
|
|---|---|
|
Age, Customized
Age of participants
|
71 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 4Tissue testosterone will be measured in biopsy tissues
Outcome measures
| Measure |
Treatment (Abiraterone Acetate and Prednisone)
n=29 Participants
Patients receive abiraterone acetate daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Abiraterone Acetate: Given orally
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Prednisone: Given orally
|
|---|---|
|
Change in Tissue Testosterone and Dihydrotestosterone
|
0.156 pg/mg
Interval 0.019 to 0.168
|
Adverse Events
Treatment (Abiraterone Acetate and Prednisone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 29 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place