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Table 1 SPIRIT flow diagram of LACOG 0415 phase II trial

From: The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels

Randomized study phase

Extension study phase

Cycle number

Screening

C1

C2

C3

C4

C5

C6

C7

PSA Confirmation

Safety visit

Patient chart data collection

Patient chart data collection

Week

0

4

8

12

16

20

25

28

Year 1

Year 2

Enrolment

Eligibility screen

X

           

Informed consent

X

           

Medical history/clinical evaluation/vital signs/physical examination/ECOG/concomitant medication assessment

X

X

X

X

X

X

X

X

 

X

  

12 lead ECG/Echocardiogram or MUGA

X

      

X

    

Interventions

Arm 1: Abiraterone + prednisona + Goserelin

 

X

X

X

X

X

X

     

Arm 2: Apalutamide monotherapy

 

X

X

X

X

X

X

     

Arm 3: Abiraterona + Prednisone + Apalutamide

 

X

X

X

X

X

X

     

Study drug accountability

 

X

X

X

X

X

X

X

    

Assessments

CT scans

       

X

    

Bone scan

          

X

 

Hematology

X

  

X

 

X

 

X

 

X

  

Biochemistry

X

 

X

X

X

X

X

X

 

X

  

PSA

X

 

X

X

X

X

X

X

X

   

Testoterone levels

X

 

X

X

X

X

X

X

X

   

Patient reported outcomes (PRO)

 

X

X

X

X

X

X

X

    

Survival Status

          

X

X

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