RecruitingNot ApplicableNCT05792722

Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

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

Sponsor

Johns Hopkins University

Enrollment

70 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a surgical technique called prostate-sparing radical cystectomy — bladder removal surgery that tries to preserve the prostate in order to protect sexual function and urinary control. Researchers want to confirm whether this approach is safe and effective without sacrificing cancer control. **You may be eligible if...** - You are 18 or older with a confirmed bladder cancer diagnosis requiring bladder removal surgery - Your cancer does not involve the prostate or the area around it - You have normal erectile function (SHIM score ≥ 17) - You have no confirmed or strongly suspected prostate cancer - You have not had prior pelvic radiation **You may NOT be eligible if...** - You are not a suitable candidate for cystectomy - You already have moderate-to-severe erectile dysfunction - Your cancer involves the prostate or bladder neck - You have confirmed prostate cancer or are at elevated genetic risk for it - You have had prior radiation to the pelvis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProstate 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.

PROCEDURENerve 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.