AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).
Who can participate
Age range18 Years
SexALL
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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 NAC followed by RC
* ECOG score 0-1
Exclusion Criteria:
* Previously intravenous chemotherapy for bladder cancer. (Patients who have had previous radiotherapy or concurrent chemo-radiation for bladder cancer are still eligible.)
* Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose NAC
* Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has 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…
What they're measuring
1
Proportion of patients with complete response at the post-operative visit after RC.
Timeframe: 15 to 90 days after radical cystectomy surgery