NCT05792722
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Recruiting · Not Applicable · Johns Hopkins University · registry updated 2025-11-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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