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Clinical Trials in Israel / NCT05155501
Recruiting Not applicable

Clinical Trial of Approaches to Prostate Cancer Surgery

NCT05155501 · tracked via the Priya Life Science Israel tracker
Sponsor
Weill Medical College of Cornell University
Phase
Not applicable
Started
2023-05-15
Last updated
2026-04-22

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
MALE
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Surgical Margin Status as assessed by surgical pathology results — 1 week post-surgery
    Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) — 6 months post-surgery
    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) — 12 months post-surgery
    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) — 24 months post-surgery
    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

Trial sites (9)

FacilityCityRegionStatus
Beckman Research Institute of City of Hope Duarte California Recruiting
Georgetown University Washington D.C. District of Columbia Recruiting
Northwestern University Chicago Illinois Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts Recruiting
Hackensack Meridian Health Hackensack New Jersey Recruiting
NewYork-Presbyterian Queens Flushing New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medicine New York New York Recruiting

More Weill Medical College of Cornell University trials in Israel

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation Recruiting
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women Recruiting

Other trials for the same condition

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer Recruiting
ExosomeDx in MRI-negative Men With High PSA Starting soon
PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy Starting soon
INTREPId (INTermediate Risk Erection PreservatIon Trial) Active, not recruiting
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05155501 on ClinicalTrials.gov ↗ ← All trials in Israel