Recruiting

Prostate Cancer SurgeryClinical Trial of Approaches to Prostate Cancer Surgery

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05155501

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Robot-assisted radical prostatectomy (RP)

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Study Details

Brief summary:

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy.

The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

Conditions

Prostate Cancer

Study ID

NCT05155501

Start date

May 15, 2023

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Robot-assisted radical prostatectomy (RP)

The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

experimental: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.

Interventions

Robot-assisted radical prostatectomy (RP)

The conventional approach to prostate cancer surgery

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Primary outcome measure

Surgical Margin Status as assessed by surgical pathology results [ Time Frame: 1 week post-surgery ]
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [ Time Frame: 6 months post-surgery ]
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [ Time Frame: 12 months post-surgery ]
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [ Time Frame: 24 months post-surgery ]

Central Contacts and Locations

Central contacts

May Ting, MBS

732-757-2448 mat7051@med.cornell.edu

Xiaohong Jing, PhD

212-746-4739 xij2004@med.cornell.edu

Locations

Beckman Research Institute of City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Radhika Nagalla, PharmD

847-502-0334 rnagalla@coh.org

Principal Investigator:

Clayton Lau, MD

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Keith Kowalczyk, MD

Keith.Kowalczyk@medstar.net

Principal Investigator:

Keith Kowalczyk, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Mary Kate Keeter, MPH

312-694-6082 mary.fitzgerald@northwestern.edu

Principal Investigator:

Edward M Schaeffer, MD PhD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rana Harb, MS

410-502-5500 rharb1@jhmi.edu

Principal Investigator:

Mohamad E Allaf, MD

Beth Israel Deaconess Medical Center (BIDMC)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriela Nieto Blanco, MS

617-632-1047 gnietobl@bidmc.harvard.edu

Sarah Duncan, BA

sduncan1@bidmc.harvard.edu

Principal Investigator:

Peter Chang, MD, MPH

Hackensack Meridian Health

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Samanta Baboolall-Aracena

551-996-3960 samanta.baboolallaracena@hmhn.org

Principal Investigator:

Nitin Yerram, MD

NewYork-Presbyterian Queens

Recruiting

Flushing, New York, United States, 11355

Contacts

Neal Patel, MD

718-303-3720 nap9055@med.cornell.edu

Principal Investigator:

Neal Patel, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Melissa McCarter

mccartem@mskcc.org

Principal Investigator:

Behfar Ehdaie, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Jim C Hu, MD MPH

646-962-9600 jch9011@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

radical prostatectomy
nerve sparing
Retzius sparing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-22.