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Clinical Trial of Approaches to Prostate Cancer Surgery

This study is comparing two types of surgery for prostate cancer: the standard Robot-assisted radical prostatectomy (RP) and a newer method called Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP). PFS-RP is designed to protect important nerves and structures that are often affected by traditional surgery, which could lead to fewer side effects like urinary problems or issues with sexual function. The study aims to see if PFS-RP can control cancer just as well as RP, while also improving your quality of life. You may be able to join if you are a man between 40 and 80 years old, scheduled for prostate cancer surgery, and can read English or Spanish. The study will measure how well the surgeries remove cancer and how your quality of life is affected. The current status of this study is unclear.

Study design
This study plans to enroll 600 men and will randomly assign them to receive either the standard or the newer surgical approach.
What's involved
Participants will undergo one of two surgical procedures. Researchers will compare cancer control and quality of life using questionnaires and medical records.
Compensation
Not stated in the trial record.
Follow-up
Cancer control will be checked at 1 week, 6 months, and 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

Recruiting
NAAges 40–80InterventionalTreatment
Weill Medical College of Cornell University
~600 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Robot-assisted radical prostatectomy (RP)Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical Margin Status as assessed by surgical pathology results
Measured over 1 week post-surgery
+3 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

9 sites across 7 states
New York3
California1
District of Columbia1
Illinois1
Maryland1
Massachusetts1
New Jersey1

Study leadership

  • Jim C Hu, MD, MPH · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

May Ting, MBS
[email protected]
732-757-2448
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Prior major pelvic surgery or radiotherapy
Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

What this trial measures

  • Surgical Margin Status as assessed by surgical pathology results1 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.