Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Recruiting · NCT05792722 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States