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Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
NCT05792722 · Johns Hopkins University
In plain English
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Official title
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
About this study
The purpose of this study is to determine if prostate capsule-sparing cystectomy improves functional outcomes without compromising the oncologic outcomes in patients with bladder cancer. The comparison arm will be patients undergoing nerve-sparing radical cystectomy. Participants will be randomized to receive either a nerve-sparing radical cystectomy or a prostate capsule-sparing radical cystectomy. Patients will be monitored following standard of care guidelines every 3-months post-operatively up to and including 24 months post-operatively. As part of standard of care post-operative follow-up patients will have routine history and physical exams, urine cytology, urine culture, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), and Prostate Specific Antigen (PSA). Standard of Care diagnostic imaging will also occur. The Sexual Health Inventory for Men (SHIM) Questionnaire will be given to patients 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post-operatively. To measure urinary function in patients who receive orthotopic neobladder, the Validated Pad Questionnaire will be given 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post operatively. Adverse Events will be monitored in both groups as defined by the CTCAE 5.0 guidelines.
Eligibility criteria
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 target: 70 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-25
Estimated completion: 2029-07
Last updated: 2025-11-18
Interventions
Procedure: Prostate capsule-sparing radical cystectomyProcedure: Nerve sparing radical cystectomy
Primary outcomes
- • 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)
Sponsor
Johns Hopkins University · other
Contacts & investigators
ContactArmine Smith, MD · contact · asmit165@jhmi.edu · 202-660-5561
ContactDomani Rodriguez · contact · drodri59@jh.edu
InvestigatorArmine Smith, MD · principal_investigator, Johns Hopkins University
All locations (2)
Sibley Memorial HospitalRecruiting
Washington D.C., District of Columbia, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States