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Evaluating Prostate-sparing Radical Cystectomy for Bladder Cancer

This study is for men with bladder cancer who need a radical cystectomy (surgery to remove the bladder). It compares two surgical approaches: prostate capsule-sparing radical cystectomy and nerve-sparing radical cystectomy. The main goal is to see if the prostate capsule-sparing surgery can improve functional outcomes, like erectile function, without affecting cancer control. You would be randomly assigned to one of the two surgery groups. Researchers will track your erectile function using a questionnaire and monitor your overall health and safety for up to two years after surgery. This study is currently recruiting men over 18 with confirmed bladder cancer.

Study design
This is an interventional study planning to enroll 70 men. Participants will be randomly assigned to receive either prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy.
What's involved
You would have surgery and then follow-up appointments every three months for up to 24 months. You would also complete questionnaires about erectile function and, if applicable, urinary function at various times.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months after surgery, with assessments of functional outcomes and safety.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05792722

Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~70 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:Prostate capsule-sparing radical cystectomyNerve sparing radical cystectomy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
Measured over 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

Conditions

Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT05792722

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins Hospital

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Sibley Memorial Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Armine Smith, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Armine Smith, MD
[email protected]
202-660-5561
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

Patients that are not candidates for cystectomy
Moderate to severe erectile dysfunction with SHIM score \<17
Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra
Prior pelvic radiation
Confirmed prostate cancer:
Patients with abnormal Digital rectal exam (DRE), PSA \>3 or Prostate Imaging Reporting \& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer
Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:
≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age
≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y
≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age
≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed
Patients with Lynch syndrome

What this trial measures

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

    Comparison of functional outcomes focusing on preservation of erectile function in patients undergoing cystectomy for bladder cancer. Functional Outcomes will be measured by the Sexual Health Inventory for Men (SHIM) Questionnaire. The Sexual Health Inventory for Men defines the following ranges of Erectile Dysfunction (ED): 1-7 is Severe ED, 8-11 Moderate ED, 12-16 Mild to Moderate ED, and 17 to 21 is Mild ED.