Recruiting

Prostate-sparing Radical Cystectomy

Sponsor:

Johns Hopkins University

Code:

NCT05792722

Conditions

Bladder Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate capsule-sparing radical cystectomy

Nerve sparing radical cystectomy

Study Details

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

Study ID

NCT05792722

Start date

Oct 25, 2023

Status verified date

Nov, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Prostate 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.

other: Nerve-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.

Interventions

Prostate 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.

Nerve 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.

Primary outcome measure

  • Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Armine Smith, MD

202-660-5561asmit165@jhmi.edu

Domani Rodriguez

drodri59@jh.edu

Locations

Sibley Memorial Hospital

Recruiting

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

Contacts

Armine Smith, MD

202-660-5561asmit165@jhmi.edu

Domani Rodriguez

drodri59@jh.edu

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Armine Smith, MD

202-660-5561asmit165@jhmi.edu

Domani Rodriguez

drodri59@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-18.