Back to resultsEvaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Primary Purpose
Bladder Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate capsule-sparing radical cystectomy
Nerve sparing radical cystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Radical Cystectomy, Prostate Capsule-Sparing Cystectomy, Nerve-Sparing Cystectomy, Male
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
Sites / Locations
- Sibley Memorial Hospital
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Prostate Capsule-Sparing Radical Cystectomy
Nerve-Sparing Radical Cystectomy
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
Comparison of functional outcomes focusing on preservation of erectile function in patients undergoing cystectomy for bladder cancer. Functional Outcomes will be measured by the Sexual Health Inventory for Men (SHIM) Questionnaire. The Sexual Health Inventory for Men defines the following ranges of Erectile Dysfunction (ED): 1-7 is Severe ED, 8-11 Moderate ED, 12-16 Mild to Moderate ED, and 17 to 21 is Mild ED.
Secondary Outcome Measures
Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire
Urinary function in patient with orthotopic neobladder urinary diversions measured using the Validated Pad Questionnaire. The Validated Pad questionnaire will be used to determine the percentage of patients utilizing 1 to 2 pads versus 2 or more pads for night and day, respectively.
Change in overall patient survival
Comparing the overall survival of patients in both arms of the study
Change in disease specific status
Comparing the status of disease specific in both arms of the study
Soft tissue surgical margin rate as assessed by pathology
Pathologists will examine the soft tissue surgical margin rate to determine positive or negative soft tissue surgical margin.
Safety as assessed by adverse events experienced by study participants
Comparing the differences in adverse events (grades 2-5) as experienced by the participants of in each study arm. The grading of adverse events are defined by the CTCAE 5.0 guidelines.
Full Information
NCT ID
NCT05792722
First Posted
March 16, 2023
Last Updated
September 26, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05792722
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Radical Cystectomy, Prostate Capsule-Sparing Cystectomy, Nerve-Sparing Cystectomy, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prostate Capsule-Sparing Radical Cystectomy
Arm Type
Other
Arm 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.
Arm Title
Nerve-Sparing Radical Cystectomy
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Prostate capsule-sparing radical cystectomy
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Nerve sparing radical cystectomy
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)
Description
Comparison of functional outcomes focusing on preservation of erectile function in patients undergoing cystectomy for bladder cancer. Functional Outcomes will be measured by the Sexual Health Inventory for Men (SHIM) Questionnaire. The Sexual Health Inventory for Men defines the following ranges of Erectile Dysfunction (ED): 1-7 is Severe ED, 8-11 Moderate ED, 12-16 Mild to Moderate ED, and 17 to 21 is Mild ED.
Time Frame
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 Outcome Measure Information:
Title
Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire
Description
Urinary function in patient with orthotopic neobladder urinary diversions measured using the Validated Pad Questionnaire. The Validated Pad questionnaire will be used to determine the percentage of patients utilizing 1 to 2 pads versus 2 or more pads for night and day, respectively.
Time Frame
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
Title
Change in overall patient survival
Description
Comparing the overall survival of patients in both arms of the study
Time Frame
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
Title
Change in disease specific status
Description
Comparing the status of disease specific in both arms of the study
Time Frame
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
Title
Soft tissue surgical margin rate as assessed by pathology
Description
Pathologists will examine the soft tissue surgical margin rate to determine positive or negative soft tissue surgical margin.
Time Frame
Up to 4-weeks after surgical intervention
Title
Safety as assessed by adverse events experienced by study participants
Description
Comparing the differences in adverse events (grades 2-5) as experienced by the participants of in each study arm. The grading of adverse events are defined by the CTCAE 5.0 guidelines.
Time Frame
Up to 24-months post-operative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armine Smith, MD
Phone
202-660-5561
Email
asmit165@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan McNamara
Phone
202-660-6133
Email
mmcnam11@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armine Smith, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armine Smith, MD
Phone
202-660-5561
Email
asmit165@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Meghan McNamara
Phone
202-660-6133
Email
mmcnam11@jhmi.edu
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armine Smith, MD
Phone
202-660-5561
Email
asmit165@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
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