Surveillance Intervals for Bladder Cancer

(VATSIT Trial)

Overseen By Florian R Schroeck, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Upper tract disease, Prostate carcinoma, Muscle-invasive carcinoma, ECOG 3 or 4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

CSP #2036 is a pragmatic, randomized, intent-to-treat, two-arm, parallel, multicenter CSP trial. Blinding of clinical staff and participants will not be possible. However, outcomes will be adjudicated by assessors blinded to randomization arm to minimize bias. Due to the pragmatic nature of the study, treatment for bladder cancer will be at the discretion of the VA participants' clinicians, and all treatments will be recorded.

Veterans with high-grade non-muscle invasive bladder cancer who underwent biopsy or transurethral resection of a bladder tumor (TURBT) in the prior 6 months will be invited to participate. After a normal first cystoscopy after TURBT (also known as "3-month cystoscopy") and additional screening, participants will be randomized 1:1 to a program of low- vs high-intensity surveillance. Stratification by stage (2 groups: Ta only vs. any T1 / any Carcinoma in situ), and site will be done because these may influence other bladder cancer-specific care, such as the threshold of when to biopsy a possible bladder lesion and whether to administer intravesical therapy.

Outcomes will be assessed during study visits every three months for 24 months, every six months after that up to 48 months, and at 60 months. Follow-up data collection beyond 60 months will be completed by phone call or participants' health record review. This will be a 10-year study with 6 years dedicated to recruitment and a minimum of 4 years dedicated to follow-up. Thus, estimated average follow-up will be 7 years and maximum follow-up will be 10 years.

Who Is on the Research Team?

Florian R Schroeck, MD MS

Principal Investigator

White River Junction VA Medical Center, White River Junction, VT

Are You a Good Fit for This Trial?

This trial is for veterans who've had high-grade non-muscle invasive bladder cancer and a recent TURBT procedure. They must have completed their first cystoscopy post-surgery without issues. The study excludes those with certain conditions or treatments that could interfere with the trial.

Inclusion Criteria

Stated willingness to comply with all study procedures

My bladder cancer is high-grade and non-invasive or has invaded the tissue beneath the lining.

VA patients with a history of high-grade non-muscle invasive urothelial carcinoma of the bladder (Inclusion of non-Veterans only allowed if they already receive clinical care at a VA medical center, e.g., via the CHAMPS program)

Exclusion Criteria

Known pregnancy at the time of study enrollment

I had bladder cancer treatment or still have upper urinary tract disease.

I have had bladder cancer that grew into the bladder muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Surveillance

Participants are randomized to either low- or high-intensity surveillance programs after a normal first cystoscopy post-TURBT

3 months

1 visit (in-person)

Surveillance

Participants undergo surveillance cystoscopy and urine cytology testing according to their assigned intensity program

24 months

Every 3 months (in-person)

Extended Surveillance

Surveillance continues with less frequent visits, every 6 months up to 48 months, then annually

36 months

Every 6 months (in-person)

Follow-up

Participants are monitored for long-term outcomes, with data collection via phone or health record review

4-10 years

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Surveillance
• Low Intensity Surveillance

Trial Overview

The study compares two monitoring approaches after bladder tumor surgery: 'Low Intensity Surveillance' versus 'High Intensity Surveillance'. Participants will be randomly assigned to one of these groups, and outcomes will be checked by blinded assessors to reduce bias.

How Is the Trial Designed?

Group I: Low Intensity Surveillance Experimental Treatment 1 Intervention

Participants assigned to low-intensity surveillance will undergo cystoscopy 12 months after transurethral resection, and then annually. They will also undergo non-invasive testing in the form of urine cytology every 3 months until month 24 after transurethral resection, then every 6 months until month 48, then annually

Group II: High Intensity Surveillance Experimental Treatment 1 Intervention

Participants assigned to high-intensity surveillance will undergo cystoscopy and urine cytology testing every 3 months until month 24 after transurethral resection, then every 6 months until month 48, then annually. This is the currently accepted surveillance schedule according to national guidelines and the VA National Oncology Bladder Cancer Clinical Pathway.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+