Clinical Trial of Approaches to Prostate Cancer Surgery

Part of paid clinical trials in Duarte, California.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05155501
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Robot-assisted radical prostatectomy (RP) — PROCEDURE
    The conventional approach to prostate cancer surgery
  • Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) — PROCEDURE
    A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Surgical Margin Status as assessed by surgical pathology results [ Time Frame: 1 week post-surgery ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Beckman Research Institute of City of HopeDuarteCalifornia91010
Radhika Nagalla, PharmD
[email protected]
847-502-0334
Clayton Lau, MD (PRINCIPAL_INVESTIGATOR)
Georgetown UniversityWashington D.C.District of Columbia20007
Keith Kowalczyk, MD
[email protected]
Keith Kowalczyk, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Mary Kate Keeter, MPH
[email protected]
312-694-6082
Edward M Schaeffer, MD PhD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Rana Harb, MS
[email protected]
410-502-5500
Mohamad E Allaf, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215
Gabriela Nieto Blanco, MS
[email protected]
617-632-1047
Sarah Duncan, BA
[email protected]
Peter Chang, MD, MPH (PRINCIPAL_INVESTIGATOR)
Hackensack Meridian HealthHackensackNew Jersey07601
Samanta Baboolall-Aracena
[email protected]
551-996-3960
Nitin Yerram, MD (PRINCIPAL_INVESTIGATOR)
NewYork-Presbyterian QueensFlushingNew York11355
Neal Patel, MD
[email protected]
718-303-3720
Neal Patel, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Melissa McCarter
[email protected]
Behfar Ehdaie, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Jim C Hu, MD MPH
[email protected]
646-962-9600

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beckman Research Institute of City of Hope· Duarte, CAGeorgetown University· Washington D.C., DCNorthwestern University· Chicago, ILJohns Hopkins University· Baltimore, MDBeth Israel Deaconess Medical Center (BIDMC)· Boston, MAHackensack Meridian Health· Hackensack, NJ

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