About this trial
This trial is looking at two ways to perform surgery for prostate cancer. The goal is to compare how well each approach controls cancer and affects patients' quality of life. One method is the standard surgery, while the other is a newer technique that aims to preserve important structures around the prostate. Researchers hope this new method will lead to better outcomes for patients.
This trial's ID number is NCT05155501. It is not in a defined phase. It plans to include about 600 participants and is not studying FDA-regulated drugs or devices.
Who can join
Adult men between 40 and 80 years old can join this trial. They need to be scheduled for surgery for localized prostate cancer and should be able to speak and read English or Spanish. Those with prior major pelvic surgery or certain lymph node issues cannot participate. The trial team will confirm if each person is eligible.
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to one of two groups. One group will undergo the standard robot-assisted radical prostatectomy, which is the usual approach. The other group will receive the new pelvic fascia-sparing surgery. Both groups will be monitored for their cancer control and quality of life after surgery.
Where
This trial is running at 9 locations in the United States. All of them are currently recruiting.
Beckman Research Institute of City of Hope
Duarte, California
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts
Georgetown University
Washington D.C., District of Columbia
Hackensack Meridian Health
Hackensack, New Jersey
Johns Hopkins University
Baltimore, Maryland
Memorial Sloan Kettering Cancer Center
New York, New York
NewYork-Presbyterian Queens
Flushing, New York
Northwestern University
Chicago, Illinois
The first 8 of 9 sites are listed here. The registry record has the full list.