TrialPath
← Back to searchRecruiting

Clinical Trial of Approaches to Prostate Cancer Surgery

NCT05155501 · Weill Medical College of Cornell University
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Clinical TrIAL of Approaches to Prostate cAncer suRgery
About this study
Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy. This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.
Eligibility criteria
Inclusion Criteria: * Male sex * Age ≥40 years or ≤80 years * Scheduled for radical prostatectomy for clinically localized prostate cancer * Able to read and speak English or Spanish * Willingness to sign informed consent and adhere to the study protocol Exclusion Criteria: * Prior major pelvic surgery or radiotherapy * Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-05-15
Estimated completion: 2026-12
Last updated: 2025-05-20
Interventions
Procedure: Robot-assisted radical prostatectomy (RP)Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
Primary outcomes
  • Surgical Margin Status as assessed by surgical pathology results (1 week post-surgery)
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) (6 months post-surgery)
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) (12 months post-surgery)
Sponsor
Weill Medical College of Cornell University · other
With: National Institutes of Health (NIH), National Cancer Institute (NCI)
Contacts & investigators
ContactMay Ting, MBS · contact · mat7051@med.cornell.edu · 732-757-2448
ContactXiaohong Jing, PhD · contact · xij2004@med.cornell.edu · 212-746-4739
InvestigatorJim C Hu, MD, MPH · principal_investigator, Weill Medical College of Cornell University
All locations (5)
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
NewYork-Presbyterian QueensRecruiting
Flushing, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Clinical Trial of Approaches to Prostate Cancer Surgery · TrialPath