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Table 2 Visit Schedule

From: Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study

  Screening & Consent Visit*
Visit 1 2 3 4 5 6 7 6 monthly visits until last visit 60 months after visit 2
Months    These below specify the months after the completion of each treatment in each arm
   0 3 12 18 24 30 31-60. Visits 4 onwards can be telephone consultations in order to note clinical outcomes although MRI scans and biopsies where done will require physical visits to the hospital
Informed Consent and enrolment into either IP4-CHRONOS A or  IP4-CHRONOS B X        
Inclusion & exclusion criteria checked, including concomitant medication review X        
Randomisation X        
Prescription of neo-adjuvant therapy X (if randomised to such arm)        Within 24hrs of randomisation
PSA blood test    X X X X X X (6 monthly)
Prostate Contrast MRI X (if randomised to focal therapy and no contrast given during diagnostic scan – to have prior to visit 2)        
Prostate mpMRI     X
(focal therapy arms)
    
Biopsy     X
(focal therapy arms)
    
Treatment   X (these vary in length)       X (focal therapy arms – a second treatment will be permitted for a histologically confirmed recurrent, residual or new out-of-field disease)
Clinical assessment (optional, only if required)    X X X X X  
PROMS questionnaires X   X X   X   X (every 12 months, at 24, 36, 48 and 60 months visits)
Review/ reporting of patient AEs/SAEs   X X X X X X X
Blood and urine tests including those for biobanking (optional) X   X X     X
  1. *Time window for each visit will be +/- 4 weeks
  2. Minimum length of follow up for the feasibility study will be 3 months from treatment for each patient. Then treatment will revert to standard of care