Comparing two surgical methods for removing the bladder in men with bladder cancer
Compares two bladder removal surgeries in men with bladder cancer, one sparing the prostate capsule.
Plain-language title generated from the registry record
Registry title: Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Key facts
- Where
- Baltimore and Washington D.C., United StatesSee the 2 sites
Where in United States
- Johns Hopkins HospitalBaltimore, United StatesTaking people
- Sibley Memorial HospitalWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT05792722
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
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.
Inclusion: 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: Prior pelvic radiation; Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra; 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:; ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed; Patients with Lynch syndrome; ≥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; Patients that are not candidates for cystectomy; Moderate to severe erectile dysfunction with SHIM score <17.