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Brief Title: Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer

INTRODUCTION

  • Org Study ID: IRB00345549
  • Secondary ID: N/A
  • NCT ID: NCT05792722
  • Sponsor: Johns Hopkins University

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.

DETAILED DESCRIPTION

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.

  • Overall Status
    Recruiting
  • Start Date
    October 25, 2023
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Armine Smith, MD

Role: Principal Investigator

Affiliation: Johns Hopkins University

Overall Contact

Name: Armine Smith, MD, Riziki' Covington

Phone: 202-660-5561, 202-660-6133

Email: asmit165@jhmi.edu, rcoving5@jh.edu

LOCATION

Facility Status Contact
Facility: Sibley Memorial Hospital
Washington, District of Columbia 20016
United States 		Status: Recruiting Contact: Contact
Armine Smith, MD
202-660-5561
asmit165@jhmi.edu

Contact
Riziki Covington
202-660-6133
rcoving5@jh.edu
Facility: Johns Hopkins Hospital
Baltimore, Maryland 21287
United States 		Status: Recruiting Contact: Contact
Armine Smith, MD
202-660-5561
asmit165@jhmi.edu

Contact
Riziki Covington
202-660-6133
rcoving5@jh.edu

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