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Table 5 Trial Flow Chart

From: Metformin and longevity (METAL): a window of opportunity study investigating the biological effects of metformin in localised prostate cancer

Phase Screening Pre-surgery Treatment Surgery Post-surgery
Time point ≤14 days before baseline Baseline Day 1 of treatment Day 21 (+/- 2 days) Day 28 (+/- 1 week) prior to surgery Day 28 (+/- 1 week) 8-10f weeks post-op
Informed consent x      
Eligibility review x x     
Randomisation   x     
Medical Historya x      
Demographics x      
Physical Exam x x x x   x
Vital signsb x   x x   x
ECOG PS x x x x   x
Height x      
Weight x    x   x
Waist/Hip ratio x    x   x
Haematology x   x x   x
Biochemistryc x   x x   x
Fasting Glucose/Lipids x    x   
PSA and Testosterone x    x   x
HbA1c x      
Whole blood and Serum saved X    X   
Study Drug Administration   x x x   
Medication review x x x x   x
Compliance evaluation (diary and verbal)    x x   
Adverse events (CTCAE v4)e   x x x   x
Paraffin embedded tissue sent to laboratory x     x  
Prostatectomy      x  
MRI safety assessmentg x      
18F Choline PET/MRIg x    Xe   
  1. aFull medical history, including history other disease, active or resolved, concomitant illnesses and cancer diagnosis
  2. bBlood pressure, pulse rate and oxygen saturation, BM
  3. cRenal profile, liver function tests, bone profile
  4. dTo be taken at selected sites only and according to the Trial specific SOP
  5. eClavien Dindo assessment to be completed at 8-10 weeks post operatively
  6. fThis review will coincide with routine post-operative review
  7. gOnly for the 5 subjects participating in the exploratory PET-MRI group