Status:
WITHDRAWN
Single-Port Versus Multi-Port Robotic Radical Prostatectomy
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Malignant Neoplasm of Prostate
Eligibility:
MALE
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two r...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging.
- Life expectancy greater than 10 years.
- Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy.
Exclusion
- Participants with any prior extensive pelvic surgery or pelvic fractures.
- Prior treatment for prostate cancer such as radiotherapy or focal therapy.
- Uncorrected coagulopathy.
- Active soft tissue or urinary infection.
- Poor surgical risk (defined as American Society of Anesthesiology score \> 3)
- Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04696263
Start Date
September 1 2022
End Date
March 1 2025
Last Update
March 10 2025
Active Locations (1)
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1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065