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Table 1 Scheduled events

From: Abiraterone acetate plus LHRH therapy versus abiraterone acetate while sparing LHRH therapy in patients with progressive, metastatic and chemotherapy-naïve, castration-resistant prostate cancer (SPARE): study protocol for a randomized controlled trial

  

Treatment phase (cycle length = 28 days)

Follow-up phase

Required investigations

Baseline day

−28 to 0

Cycle 1

Day 1

Cycle 1

Day 15

Cycle 2 and 3

Day 1

Cycles 4, 7, 10 (continue every 3rd cycle) Day 1

Any other cycle, Day 1

At treatment

discontinuation

End-of-treatment

visit

Follow-up visit

(every 3 months)

Procedures

 Signed consent form

X

        

 Medical history, prior

Prostate cancer therapies

X

        

 Worst pain within last 24 h

X

X

X

X

X

X

 

X

 

 Physical exam and weight

X

 

X

X

X

X

 

X

 

 Vital signs

X

X

X

X

X

X

 

X

 

 ECOG

X

X

X

X

X

X

 

X

 

 12-lead ECG

X

   

X

  

X

 

Cardiac echo

X

   

X

    

 Dosing compliance

  

X

X

X

X

 

X

 

 Concomitant medication

X

X

X

X

X

X

 

X

 

 Adverse events

X

X

X

X

X

X

 

X

X

Laboratory assessments

 Hematology

X

  

X

X

X

 

X

 

 Serum chemistry, electrolytes

X

 

X

X

X

X

 

X

 

 Liver function test

X

 

X

X

X

X

 

X

 

 Serum lipids

X

 

X

X

X

    

 Plasma glucose

X

 

X

X

X

X

 

X

 

 PSA

 

X

 

X

X

X

 

X

X

 Serum testosterone, hormones

 

X

 

X

X

 

X

X

 

Tumor assessments

 CT/MRI

X

   

X

  

X

X

 Bone scan

X

   

X

  

X

X

 Disease progression assessments

    

X

 

X

X

X

 Next therapy for prostate cancer

        

X

  1. CT computed tomography, ECG electrocardiogram, ECOG, Eastern Cooperative Oncology Group, MRI magnetic resonance imaging, PSA prostate-specific antigen