TY - JOUR
T1 - Clinical Trial Protocol for “Replace Cysto”
T2 - Replacing Invasive Cystoscopy with Urine Testing for Non–muscle-invasive Bladder Cancer Surveillance—A Multicenter, Randomized, Phase 2 Healthcare Delivery Trial Comparing Quality of Life During Cancer Surveillance with Xpert Bladder Cancer Monitor or Bladder EpiCheck Urine Testing Versus Frequent Cystoscopy
AU - Schroeck, Florian R.
AU - Grubb, Robert
AU - MacKenzie, Todd A.
AU - Ould Ismail, A. Aziz
AU - Jensen, Laura
AU - Tsongalis, Gregory J.
AU - Lotan, Yair
N1 - Publisher Copyright:
© 2024
PY - 2024/5
Y1 - 2024/5
N2 - “Replace Cysto” is a multisite randomized phase 2 trial including 240 participants with low-grade intermediate-risk non–muscle-invasive bladder cancer, in which participants will be randomized 1:1:1 to one of two urine marker–based approaches alternating a urine marker test (Xpert Bladder Cancer Monitor or Bladder EpiCheck) with cystoscopy or to frequent scheduled cystoscopy. The primary objective is to determine whether urinary quality of life after surveillance is significantly improved in the urine marker arms. The primary outcome will be the patient-reported urinary quality of life domain score of the validated QLQ-NMIBC24 instrument, measured 1–3 d after surveillance. Exploratory outcomes include discomfort after surveillance, the number of invasive procedures that participants undergo per 1000 person years, complications from these procedures per 1000 person years, nonurinary quality of life, acceptability of surveillance, and bladder cancer recurrence and progression. Comparators include surveillance using (1) the Xpert Bladder Cancer Monitor test, (2) the Bladder EpiCheck urinary marker, or (3) frequent cystoscopy alone. After a negative cystoscopy ≤4 mo following bladder tumor resection, all the participants will undergo surveillance at 6, 12, 18, and 24 mo (with time zero defined as the date of the most recent bladder tumor resection). In the urine marker arms, surveillance at 6 and 18 mo will be performed with the marker. Regardless of the arm, participants will undergo cystoscopy at 12 and 24 mo. End of study for each participant will be their 24-mo cystoscopy. Overall trial duration is estimated at 5 yr from when the study opens to enrollment until completion of data analyses. The trial is registered at clinicaltrials.gov (NCT05796375).
AB - “Replace Cysto” is a multisite randomized phase 2 trial including 240 participants with low-grade intermediate-risk non–muscle-invasive bladder cancer, in which participants will be randomized 1:1:1 to one of two urine marker–based approaches alternating a urine marker test (Xpert Bladder Cancer Monitor or Bladder EpiCheck) with cystoscopy or to frequent scheduled cystoscopy. The primary objective is to determine whether urinary quality of life after surveillance is significantly improved in the urine marker arms. The primary outcome will be the patient-reported urinary quality of life domain score of the validated QLQ-NMIBC24 instrument, measured 1–3 d after surveillance. Exploratory outcomes include discomfort after surveillance, the number of invasive procedures that participants undergo per 1000 person years, complications from these procedures per 1000 person years, nonurinary quality of life, acceptability of surveillance, and bladder cancer recurrence and progression. Comparators include surveillance using (1) the Xpert Bladder Cancer Monitor test, (2) the Bladder EpiCheck urinary marker, or (3) frequent cystoscopy alone. After a negative cystoscopy ≤4 mo following bladder tumor resection, all the participants will undergo surveillance at 6, 12, 18, and 24 mo (with time zero defined as the date of the most recent bladder tumor resection). In the urine marker arms, surveillance at 6 and 18 mo will be performed with the marker. Regardless of the arm, participants will undergo cystoscopy at 12 and 24 mo. End of study for each participant will be their 24-mo cystoscopy. Overall trial duration is estimated at 5 yr from when the study opens to enrollment until completion of data analyses. The trial is registered at clinicaltrials.gov (NCT05796375).
KW - Bladder cancer
KW - Bladder–cancer-specific quality of life
KW - Cancer surveillance
KW - Urinary tumor markers
UR - http://www.scopus.com/inward/record.url?scp=85188567052&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85188567052&partnerID=8YFLogxK
U2 - 10.1016/j.euros.2024.02.018
DO - 10.1016/j.euros.2024.02.018
M3 - Article
C2 - 38558761
AN - SCOPUS:85188567052
SN - 2666-1691
VL - 63
SP - 19
EP - 30
JO - European Urology Open Science
JF - European Urology Open Science
ER -