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A Phase II Trial of Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN BLADDER)

BACKGROUND

  • Cisplatin-based neoadjuvant chemotherapy followed by cystectomy or chemoradiation is the standard of care for urothelial carcinoma patients with muscle invasive bladder cancer.
  • Both cystectomy and chemoradiation carry potential short and long-term toxicity and quality of life implications.
  • Recent work has shown that mutations in DNA damage repair/response genes are predictive of pathologic response to neoadjuvant chemotherapy at the time of cystectomy, with those patients achieving pT0 disease demonstrating excellent long-term survival.1-4
  • Sparing patients cystectomy or chemoradiation after neoadjuvant chemotherapy without compromising oncologic outcomes would improve quality of life and decrease morbidity.

OBJECTIVES

  • Primary Aim: To evaluate a risk-adapted approach to the treatment of muscle invasive bladder cancer.
  • Primary Objective: To evaluate the metastasis-free survival at 2 years for all patients
  • Key Secondary Objectives:
    • To assess the rate of any urothelial carcinoma recurrence in active surveillance patients
    • To assess bladder preservation rates with neoadjuvant AMVAC and subsequent risk-adapted treatment
    • To assess the feasibility of an Endoscopic Tumor Quantification System
    • To assess quality of life with neoadjuvant AMVAC and subsequent risk-adapted treatment (EORTC QLQ-BLM 30, SHIM, FSFI, AUA symptoms score)
    • To assess genomic correlates and mutations in urinary cellfree DNA.
    • To assess toxicity in each treatment arm

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