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Procedure

Prostate-Sparing Cystectomy for Bladder Cancer

N/A

Recruiting

Led By Armine Smith, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy

Age > 18 years old

Must not have

Confirmed prostate cancer

Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if removing just the prostate, instead of the whole bladder, can improve quality of life while still treating prostate cancer.

Who is the study for?

This trial is for men over 18 with bladder cancer who are scheduled for radical cystectomy, understand the study, and consent to participate. Men with prior pelvic radiation, Lynch syndrome, confirmed prostate cancer, moderate/severe erectile dysfunction (SHIM score <17), or increased genetic risk of prostate cancer aren't eligible.

What is being tested?

The trial compares two surgical methods: nerve-sparing and prostate capsule-sparing radical cystectomy. It aims to see if preserving the prostate capsule improves sexual and urinary functions without affecting cancer treatment outcomes.

What are the potential side effects?

Potential side effects include those typical of major surgery such as pain, bleeding, infection risks post-operation. Specific side effects related to each surgical method will be monitored through patient questionnaires on erectile and urinary functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have bladder cancer and am scheduled for complete bladder removal.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with prostate cancer.

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My bladder cancer affects the bladder neck or prostate.

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I have Lynch syndrome.

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I am not a candidate for surgical removal of my bladder.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)

Secondary study objectives

Change in disease specific status

Change in overall patient survival

Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prostate Capsule-Sparing Radical CystectomyExperimental Treatment1 Intervention

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.

Group II: Nerve-Sparing Radical CystectomyExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met