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

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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)

INTRODUCTION

  • Org Study ID: CASE5824
  • Secondary ID: N/A
  • NCT ID: NCT06290687
  • Sponsor: Case Comprehensive Cancer Center

BRIEF 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.

DETAILED DESCRIPTION

Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.

  • Overall Status
    Recruiting
  • Start Date
    July, 2026
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence-Free Survival (RFS)

Primary Outcome 1 - Timeframe: Up to 24 months from date of post-surgery baseline scan

CONDITION

  • Malignant Neoplasm of Bladder
  • Muscle Invasive Bladder Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nima Almassi, MD

Role: Principal Investigator

Affiliation: Cleveland Clinic, Case Comprehensive Cancer Center

Overall Contact

Name: Nima Almassi, MD

Phone: (216) 444-1825

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States 		Status: Recruiting Contact: Contact
Nima Almassi, MD
216-444-1825
[email protected]

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