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Trial Title:
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
NCT ID:
NCT05792722
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Radical Cystectomy
Prostate Capsule-Sparing Cystectomy
Nerve-Sparing Cystectomy
Male
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Prostate capsule-sparing radical cystectomy
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 group label:
Prostate Capsule-Sparing Radical Cystectomy
Intervention type:
Procedure
Intervention name:
Nerve sparing radical cystectomy
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.
Arm group label:
Nerve-Sparing Radical Cystectomy
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Armine Smith, MD
Phone:
202-660-5561
Email:
asmit165@jhmi.edu
Contact backup:
Last name:
Riziki Covington
Phone:
202-660-6133
Email:
rcoving5@jh.edu
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Armine Smith, MD
Phone:
202-660-5561
Email:
asmit165@jhmi.edu
Contact backup:
Last name:
Riziki Covington
Phone:
202-660-6133
Email:
rcoving5@jh.edu
Start date:
October 25, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792722
