A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY
Phase: PHASE2
Conditions: Prostate Cancer
Sponsor: Sun Pharmaceutical Industries Limited



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