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Trial of Modifications to Radical Prostatectomy

NCT01407263 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3204

Last updated 2025-08-14

No results posted yet for this study

Summary

This trial will evaluate whether the following aspect of surgical technique influence outcome: Lymph node dissection. In some patients, scans taken before surgery show that a lymph node has cancer. Surgeons make sure to remove those affect lymph nodes and all other lymph nodes in the area. However, it is not known whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes. In this study, patients with clear scans will either receive a lymph node dissection or not."

Conditions

Interventions

PROCEDURE

Lymph node template

Inclusion of the external iliac, hypogastric and obturator fossa nodal groups in the template undergoing a Radical Prostatectomy. Modifying the template for lymph node dissection may lead to removal of additional affected nodes, reducing the chance of recurrence. .No lymph nodes will be removed in patients randomized to the no PLND arm.

PROCEDURE

Transverse versus vertical closure

Transverse versus vertical closure of the port site incision

DRUG

antibiotic prophylaxis

One vs. three days of antibiotic prophylaxis at catheter removal

DRUG

Hemostatic Agent

For the patients randomized to routine indwelling HA agent use, the operating surgeon may choose to use either Surgicel™, Surgicel SNoW™, Arista™, FloSeal or surgeon's choice HA directed at the prostatic fossa, ligated dorsal vein complex, or neurovascular bundles. Because there is no standard HA or method of application, the surgeon will apply the HA according to the surgeon's experience and document both the HA used, and the location applied in the operative report. For patients randomized to no routine indwelling HA use, surgeons will only apply a HA if they are unable to achieve hemostasis using traditional means or feel it would be unsafe to complete the operation without using a HA for additional hemostasis. Providers in either arm may use HA as needed provided the intention is not to leave the HA indwelling.

Sponsors & Collaborators

Principal Investigators

  • Andrew Vickers, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407263 on ClinicalTrials.gov