Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Johns Hopkins University

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Procedure: Prostate capsule-sparing radical cystectomy; Procedure: Nerve sparing radical cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05792722

IRB00345549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Prostate Capsule-Sparing Radical Cystectomy

Other group

Description:

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.

Treatment:

Procedure: Prostate capsule-sparing radical cystectomy

Nerve-Sparing Radical Cystectomy

Other group

Description:

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.

Treatment:

Procedure: Nerve sparing radical cystectomy