Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT05792722
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prostate capsule-sparing radical cystectomy — PROCEDURE
    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.
  • Nerve sparing radical cystectomy — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Nov 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM) [ Time Frame: Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Armine Smith, MD
[email protected]
202-660-5561
Domani Rodriguez
[email protected]
Johns Hopkins HospitalBaltimoreMaryland21287
Armine Smith, MD
[email protected]
202-660-5561
Domani Rodriguez
[email protected]

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