Clinical trial NCT05792722: Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Official title: A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: Radical Cystectomy
Prostate Capsule-Sparing Cystectomy
Nerve-Sparing Cystectomy
Male
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
timeFrame: 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
Secondary outcomes:
measure: Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire
timeFrame: 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
measure: Change in overall patient survival
timeFrame: 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
measure: Change in disease specific status
timeFrame: 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
measure: Soft tissue surgical margin rate as assessed by pathology
timeFrame: Up to 4-weeks after surgical intervention
measure: Safety as assessed by adverse events experienced by study participants
timeFrame: Up to 24-months post-operative
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Armine Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: