Table 1.
Overview of study visits for participants of the PRE-PREVENCYS trial
| Pre-treatment | NACe week 3–15 |
Surgery | Follow-up | ||||
|---|---|---|---|---|---|---|---|
| Visit | Visit 0 | Visit 1 | Visit 2 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
| Week | -2 | 0 | 2 | 7–8 or 11–12 | 15–16 | 20–22 | 32–35 |
| Informed consent | X* | ||||||
| Inclusion | X* | ||||||
| ECOG performance status | X | ||||||
| Liquid biopsya | X* | X* | |||||
| Urine cytology | X | X* | |||||
| Blood hematologyb and biochemistryc | X | X | |||||
| Staging 18F-FDG-PET/CTd | X | ||||||
| CRE1f | X | ||||||
| (optional) CRE2f | X | ||||||
| BME, cystoscopy and TURg | X* | ||||||
| RC with ePLND | X | ||||||
| CRE3f | X | ||||||
a Collection of blood and urine for biomarker analyses
b Hematology: complete blood count, white blood differential, CRP
c Biochemistry: serum albumin, electrolytes, serum creatinine, bilirubin, alkaline phosphatase, AST, ALT, LDH
c FDG PET/CT of thorax and abdomen for staging purposes
e At least three cycles of cisplatin-based NAC, i.e. 3w Gemcitabin/Cisplatin or 2w dose-dense Methotrexate, Vinblastine, Adriamycin and Cisplatin
f CRE: CT scanning of thorax and abdomen. CRE1 after three cycles of NAC; optional CRE1 after two cycles of NAC in combination with an additional CRE2 after completion of NAC; and CRE3 at three months post-surgery
g Prior but in the same session of RC at the operation room. TUR of lesions suspected for tumour, or scar tissue
* Study-related actions or interventions
BME: bimanual examination; CRE: clinical response evaluation; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; ePLND: extended pelvic lymph node dissection; 18F-FDG: 2-Deoxy-2-[18F] fluorodeoxyglucose; NAC: neoadjuvant chemotherapy; PET: positron-emission tomography; RC: radical cystectomy; TUR: transurethral resection