Table 2 Visit Schedule
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 | ||||