Actively Recruiting
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Led by Johns Hopkins University · Updated on 2025-11-18
70
Participants Needed
2
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed bladder cancer and scheduled for radical cystectomy
- Variant histologies of bladder cancer are allowed
- Neoadjuvant therapy is permitted
- Age over 18 years
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Not a candidate for cystectomy
- Moderate to severe erectile dysfunction with SHIM score less than 17
- Bladder cancer involving bladder neck or prostate, including prostatic urethra cancer
- Prior pelvic radiation
- Confirmed prostate cancer or abnormal prostate exam or elevated PSA over 3
- Increased genetic risk of prostate cancer per NCCN guidelines
- Diagnosis of Lynch syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
A
Armine Smith, MD
CONTACT
D
Domani Rodriguez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here