Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
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

Detailed description:
This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.

Arms:
arm 1: 1,000 MG (4 x 250 mg qd) arm 2: 500 mg (4 x 125 mg qd)

Interventions: intervention 1: Zytiga® (Abiraterone Acetate) intervention 2: SoluMatrix™ (Abiraterone Acetate)
Intervention descriptions: intervention 1: 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 intervention 2: SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart

Protocol document:
Prot_SAP_000.pdf: 






















3 
TABLE OF CONTENTS 
1 
INVESTIGATOR APPROVAL STATEMENT . .  o o  0 0  o o  • • • • • • • • • •  o o  0 0  o o  • • • • • • • • • •  o o  0 0  o o  • • • • • • • • • •  o o  0 0  o o .  3 
2 
PROTOCOL SYNOPSIS ............................................................................................ 4 
3 
TABLE OF CONTENTS ........................................................................................... 12 
4 
LIST OF ABBREVIATIONS .................................................................................... 15 
5 
INTRODUCTION ..................................................................................................... 1 7  
5.1 
Backgrmmd and Rationale ............................................................................... 1 7  
5.2 
Clinical and Nonclinical Experience ................................................................ 18 
5.3 
Selection of the Doses Used in the Study ........................................................ 19 
5.4 
Sumruy of Potential Risks and Benefits ........................................................ 19 
5.4.1 
Potential Risks Associated with Abiraterone Acetate .......................... 20 
5.4.2 
Potential Risks Associated with Corticosteroids (Prednisone and 
Methylprednisolone) ............................................................................. 21 
6 
OBJECTIVE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21 
7 
STUDY DESIGN ....................................................................................................... 21 
8 
PATIENT POPULATION ......................................................................................... 22 
8.1 
Selection of Study Population .......................................................................... 22 
8 .1.1 
Inclusion Criteria .................................................................................. 22 
8.1.2 
Exclusion criteria .................................................................................. 23 
8.1.3 
Restrictions ........................................................................................... 25 
8.1.4 
Removal of Patients from Therapy or Assessment .............................. 25 
9 
STUDY PROCEDURES ........................................................................................... 26 
9.1 
Screening (Day -28 to -1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  26 
9 .1.1 
Visit 1, Screening ................................................................................. 26 
9.2 
Detennination of Patient Eligibility, Randornization ....................................... 2 7  
9 .2.1 
Visit 2 ,  Randornization, Day 1 ............................................................. 2 7  
9.3 
Treatlnent Period .............................................................................................. 28 
9.3.1 
Day 8 ..................................................................................................... 28 
9.3.2 
Visit3,Day9 ........................................................................................ 28 
9.3.3 
Visit4 ,Day10 ...................................................................................... 29 
9.3.4 
Day21 ................................................................................................... 30 
9.3.5 
Visit5,Day28 ...................................................................................... 30 
9.4 
Extension Period .............................................................................................. 31 
9.4.1 
Day 42 ................................................................................................... 31 
9.4.2 
Visit 6, Day 56 ...................................................................................... 31