Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)
The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.
• Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.
• Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.
• Age \>18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study.
• Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
• Subjects must have normal organ and marrow function as defined below:
‣ Total bilirubin within normal limits
⁃ AST (SGOT) ≤ 2.5 X institutional upper limit of normal
⁃ ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
⁃ Bone marrow:
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
∙ Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
• Treatment naive for MIBC.