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RECRUITING

NCT06290687

PHASE2

Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-18

Completion Date

2027-12-29

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Malignant Neoplasm of Bladder Muscle Invasive Bladder Carcinoma

Interventions

DRUG

Neoadjuvant Chemotherapy

Standard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include: * Cisplatin - Gemcitabine (Gem/Cis) * Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)

PROCEDURE

Partial cystectomy with Extended pelvic lymph node dissection

Partial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.

DRUG

Adjuvant systemic therapy

Standard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.

Inclusion Criteria: * 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. Exclusion Criteria: * Presence of hydronephrosis. * Presence of multifocal disease that is not amenable to complete resection with partial cystectomy. * Presence of distant carcinoma in situ. * Presence of clinical N+ or M+ disease. * Presence of cT4+ disease. * Non-urothelial histology. * Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma. * Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment. * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Locations (1)

Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States