The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate
This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart
SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
Alliance Research
Laguna Hills, California, United States
Tower Urology
Los Angeles, California, United States
Testosterone Levels
Blood Sample tested for Serum Testosterone Levels
Time frame: Average of Day 9 and 10
PSA Levels
All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint
Time frame: Day 28, Day 56, and Day 84
Percent of Subjects With PSA-50 Response
Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
Time frame: Day 28, Day 56, and Day 84
Serum Testosterone Levels
These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
Time frame: Day 28, Day 56, and Day 84
Steady State Trough Concentration of Arbiraterone
These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
Time frame: Day 09, Day 28, Day 56, and Day 84
AUC (0-inf)
Steady state systemic exposure parameters
Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
AUC (0-24 hr)
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
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San Bernardino Urological
San Bernardino, California, United States
Skyline Urology
Torrance, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Urology Associates, P.C.
Englewood, Colorado, United States
Manatee Medical Research
Bradenton, Florida, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Wichita Urology Group
Wichita, Kansas, United States
...and 7 more locations
Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
AUC (0-t)
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
Cmax
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose