NCT06290687WithdrawnPhase 2
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC 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)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Reason given: PI left institution
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 26 Feb 2024
- Start date
- Sept 2026
- Primary completion date
- 29 Dec 2026
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Bladder cancer
- NCT number
- NCT06290687
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
- Presence of clinical N+ or M+ disease.
- Presence of cT4+ disease.
- 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.
Other
- Presence of hydronephrosis.
- Presence of distant carcinoma in situ.
- Non-urothelial histology.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.