Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Inclusion Criteria:

• Pathologically (histologically or cytologically) proven diagnosis of primaryurothelial carcinoma of the bladder. Subjects with mixed histology are required tohave a dominant traditional cell carcinoma (TCC) pattern.

• Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive,chemoradiation of the bladder

• Planned TURBT as part of the normal course treatment, to take place prior to theinitiation of chemo irradiation

• Adequate renal function: Serum creatinine < 2 mg/dL OR calculated creatinineclearance (CrCl) > 30ml/min

• Ability to understand and willingness to sign a written informed consent

• Women of child-bearing potential and men must agree to use adequate contraceptionprior to study entry, during study participation, and for 90 days after studytreatment discontinuation

• Should a woman become pregnant or suspect she is pregnant while she or herpartner is participating in this study, she should inform her treatingphysician immediately

Exclusion Criteria:

• Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC ofthe bladder, are not allowed

• Known distant metastatic disease (e.g. pulmonary or hepatic metastases)

• Subjects with malignant lymphadenopathy in the abdomen or pelvis consideredappropriate for radical cystectomy and lymphadenectomy with the goal ofcomplete resection of all malignant disease are allowed

• Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)

• Planned (or prior history of) definitive bladder irradiation

• Intravesical chemo- or biologic therapy within 6 weeks of first treatment

• Any planned neoadjuvant systemic immunotherapy. Note that prior bacilleCalmette-Guerin vaccine (BCG) is not an exclusion

• Clinically significant active infection or uncontrolled medical condition that wouldpreclude participation in study

• Pregnant or nursing women are excluded

• Previous malignancy other than TCC that, in the opinion of the treatinginvestigator, is likely to interfere with protocol treatment

• Individuals with severe renal failure and cannot receive MRI contrast