Trial Outcomes & Findings for Abiraterone Acetate Trial in African American Prostate Cancer Patients (NCT NCT01735396)
NCT ID: NCT01735396
Last Updated: 2017-05-12
Results Overview
The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
TERMINATED
PHASE2
11 participants
baseline and 12 weeks
2017-05-12
Participant Flow
Recruitment began in Dec 2012, with enrollment from April 2014 to March 2016.
Participant milestones
| Measure |
Abiraterone Acetate
Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate
Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Overall Study
not evaluable
|
1
|
Baseline Characteristics
Abiraterone Acetate Trial in African American Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=11 Participants
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Number of prior systemic therapies
|
3 prior therapies
n=5 Participants
|
|
Performance Status: ECOG
ECOG 0
|
8 Participants
n=5 Participants
|
|
Performance Status: ECOG
ECOG 1
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksThe primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.
Outcome measures
| Measure |
Abiraterone Acetate
n=10 Participants
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Number of Participants With ≥ 30% Change in PSA
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPost-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Abiraterone Acetate
n=10 Participants
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Response Assessment
PR
|
9 Participants
|
|
Response Assessment
SD
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: data not collected
post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: data not collected
post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weeksTo determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5
Outcome measures
| Measure |
Abiraterone Acetate
n=10 Participants
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
Safety of Abiraterone
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: data not collected
Post-treatment changes in testosterone
Outcome measures
Outcome data not reported
Adverse Events
Abiraterone Acetate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abiraterone Acetate
n=10 participants at risk
Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
|
|---|---|
|
General disorders
Fatigue
|
70.0%
7/10
|
|
General disorders
Hot flashes
|
40.0%
4/10
|
|
General disorders
Nausea
|
40.0%
4/10
|
|
General disorders
Vomiting
|
40.0%
4/10
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10
|
|
General disorders
Cough
|
30.0%
3/10
|
|
Metabolism and nutrition disorders
Alkaline phosphatase level increased
|
70.0%
7/10
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
4/10
|
|
Renal and urinary disorders
Urinary incontinence
|
30.0%
3/10
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
5/10
|
|
General disorders
Diarrhea
|
20.0%
2/10
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
40.0%
4/10
|
|
General disorders
Anorexia
|
30.0%
3/10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness in lower limb
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase level increased
|
30.0%
3/10
|
|
Metabolism and nutrition disorders
Alanine aminotransferase level increased
|
20.0%
2/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10
|
Additional Information
Dr. Matthew David Galsky
Tisch Cancer Center, Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place