Clinical trial · Interventional
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nerve sparing radical cystectomy | Procedure | — | UNRESOLVED |
| Prostate capsule-sparing radical cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Prostate Capsule-Sparing Radical Cystectomy
- description
- Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.
- interventionNames
- Procedure: Prostate capsule-sparing radical cystectomy
- type
- OTHER
- label
- Nerve-Sparing Radical Cystectomy
- description
- Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.
- interventionNames
- Procedure: Nerve sparing radical cystectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy * Variant histologies of bladder cancer permitted * Neoadjuvant therapy permitted * Age \> 18 years old * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Patients that are not candidates for cystectomy * Moderate to severe erectile dysfunction with SHIM score \<17 * Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra * Prior pelvic radiation * Confirmed prostate cancer: * Patients with abnormal Digital rectal exam (DRE), PSA \>3 or Prostate Imaging Reporting \& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer * Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines: * ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age * ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y * ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age * ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed * Patients with Lynch syndrome
References
Publications (0)
Data not yet available