Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

NCT05792722 | Recruiting DMC

• 1 other identifier: IRB00345549
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bladder Cancer

Keywords

Radical Cystectomy; Prostate Capsule-Sparing Cystectomy; Nerve-Sparing Cystectomy; Male

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Secondary Outcomes (5)

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

  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

• Change in overall patient survival

  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

• Change in disease specific status

  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

• Soft tissue surgical margin rate as assessed by pathology

  Up to 4-weeks after surgical intervention

• Safety as assessed by adverse events experienced by study participants

  Up to 24-months post-operative

Study Arms (2)

Prostate Capsule-Sparing Radical Cystectomy

OTHER

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.

Procedure: Prostate capsule-sparing radical cystectomy

Nerve-Sparing Radical Cystectomy

OTHER

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.

Procedure: Nerve sparing radical cystectomy

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.

Prostate Capsule-Sparing Radical Cystectomy

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.

Nerve-Sparing Radical Cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Armine Smith, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armine Smith, MD

CONTACT

202-660-5561; asmit165@jhmi.edu

Domani Rodriguez

CONTACT

drodri59@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 31, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (2)