AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

Inclusion Criteria:

• Histologically confirmed diagnosis of transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant [50%+]histology)

• Clinical stage T2-T4a N0-N2 M0 by CT (or MRI) + PET/CT

• Elected and fit according to institutional guidelines for cisplatin-based NACfollowed by RC

• ECOG score 0-1

Exclusion Criteria:

• Previously intravenous chemotherapy for bladder cancer. (Patients who have hadprevious radiotherapy or concurrent chemo-radiation for bladder cancer are stilleligible.)

• Currently participating or has participated in a study of an investigational agentand received study therapy or received investigational device within 4 weeks beforethe first dose NAC

• Known additional malignancy that is progressing or requires active treatment exceptfor basal cell carcinoma of the skin, or squamous cell carcinoma of the skin thathas undergone potentially curative therapy, or in situ cervical cancer.

(A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower, Gleason score less/equal to 7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year before study allocation. Pathological evidence of concurrent T1a/b prostate cancer after radical cystecto-prostatectomy are still eligible.)

• Evidence of measurable nodal or metastatic disease.