RecruitingNot ApplicableNCT05792722

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

Sponsor

Johns Hopkins University

Enrollment

70 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria12

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

Interventions

PROCEDUREProstate 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.

PROCEDURENerve 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.