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RECRUITING
NCT05792722
NA

Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-10-25

Completion Date

2029-07

Last Updated

2025-11-18

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Prostate capsule-sparing radical cystectomy

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.

PROCEDURE

Nerve sparing radical cystectomy

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.

Locations (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States