Prediction of pathological response following neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer: the PRE-PREVENCYS trial

Table 1 Overview of study visits for participants of the PRE-PREVENCYS trial

	Pre-treatment			NAC^e 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 biopsy^a		X*				X*
Urine cytology		X				X*
Blood hematology^b and biochemistry^c		X				X
Staging ¹⁸F-FDG-PET/CT^d			X
CRE1^f				X
(optional) CRE2^f					X
BME, cystoscopy and TUR^g						X*
RC with ePLND						X
CRE3^f							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

ISSN: 1471-2407