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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I have bladder cancer and am scheduled for complete bladder removal.
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I am older than 18 years.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,427 Total Patients Enrolled
Armine Smith, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

Nerve sparing radical cystectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05792722 — N/A
Bladder Cancer Research Study Groups: Prostate Capsule-Sparing Radical Cystectomy, Nerve-Sparing Radical Cystectomy
Bladder Cancer Clinical Trial 2023: Nerve sparing radical cystectomy Highlights & Side Effects. Trial Name: NCT05792722 — N/A
Nerve sparing radical cystectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05792722 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project still have open slots for participants?

"This medical trial is no longer enrolling participants, as per the information accessible on clinicaltrials.gov. The study initially began recruiting patients on July 1st of 2023 and was last updated June 12th of 2023. Despite this particular trial's closure, there are presently 385 other trials actively searching for enrollees."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
2023. "Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05792722.
~47 spots leftby Jul 2026
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