Bladder - Non-Metastatic

Key Eligibility Criteria:
Inclusion:
1. Histologically confirmed urothelial cancer of the bladder.
2. Radical cystectomy ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Radical cystectomy ≤ 18 weeks prior to registration.
3. No evidence of residual cancer or metastases after surgery (imaging required prior to registration)
4. Available tumor tissue for “central” Signatera testing to be submitted after pre-registration. Must have evaluable ctDNA Signatera assay result [i.e., ctDNA(+) or ctDNA(-)] based on test performed as part of “central testing” after pre-registration to A032103.
a. Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing.
5. All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or < 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.

For pre-screening, please contact: Message Basket: VICC RESEARCH UROTHELIAL

Key Eligibility Criteria:
Inclusion Criteria:
1. Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.
a. Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible.
2. Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection
3. Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fludeoxyglucose (FDG) PET Imaging is acceptable for radiological staging
4. No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy
5. No definitive clinical or radiologic evidence of metastatic disease
6. Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy
7. For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization
8. Must not have had prior pelvic radiation
9. Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified


For pre-screening, please contact: Individual disease research teams.