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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Armine Smith, MD
asmit165@jhmi.edu
202-660-5561
Backup
Riziki' Covington
rcoving5@jh.edu
202-660-6133
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2026-07
Participants
Target number of participants: 70
Treatments
Other: 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.
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov