Partial bladder removal with extended pelvic lymph node dissection plus standard perioperative systemic therapy

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)

This trial will test whether partial bladder removal with extended pelvic lymph node removal plus standard perioperative systemic therapy can treat adults with muscle-invasive bladder cancer who are candidates for bladder-sparing surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Case Comprehensive Cancer Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06290687 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives eligible adults neoadjuvant systemic therapy for about 4–6 weeks, followed by a partial cystectomy with extended pelvic lymph node dissection and subsequent adjuvant systemic therapy. The protocol focuses on surgical bladder preservation rather than complete bladder removal while using contemporary imaging and perioperative care. Outcomes collected include surgical safety, oncologic efficacy (pathologic and clinical outcomes), and patient-reported health-related quality of life. The study targets patients with unifocal or limited multifocal T2–T3 N0 M0 urothelial carcinoma who are judged amenable to complete resection with a partial cystectomy.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed urothelial muscle-invasive bladder cancer staged T2–T3 N0 M0, unifocal or limited multifocal disease amenable to complete partial cystectomy, good performance status (KPS ≥70 or ECOG 0–1), and adequate organ and marrow function.

Not a fit: Patients with extensive or multifocal tumors not amenable to partial cystectomy, node-positive or metastatic disease, poor performance status, or inadequate organ function are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could control the cancer while preserving the bladder, lowering surgical morbidity, and improving quality of life.

How similar studies have performed: Partial cystectomy has been reported in retrospective series and is included as a guideline option for select patients, but high-quality prospective data with modern imaging and perioperative systemic therapy are limited, making this Phase 2 approach relatively novel.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Nima Almassi, MD — Cleveland Clinic, Case Comprehensive Cancer Center
• Study coordinator: Nima Almassi, MD

Conditions: Malignant Neoplasm of Bladder, Muscle Invasive Bladder Carcinoma, Partial cystectomy, Pelvic Lymph Node Dissection