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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