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ACTIVE NOT RECRUITING
NCT01407263
PHASE3

Trial of Modifications to Radical Prostatectomy

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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."

Official title: A Randomized Trial of Modifications to Radical Prostatectomy

Key Details

Gender

MALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3204

Start Date

2011-07

Completion Date

2026-07

Last Updated

2025-08-14

Healthy Volunteers

No

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.

Locations (5)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, United States