Trial of Modifications to Radical Prostatectomy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,204

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Prostate Cancer
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.

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only), Uniondale

07920

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge

07645

Memorial Sloan Kettering Bergen (Consent Only), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01407263 - Trial of Modifications to Radical Prostatectomy | Biotech Hunter | Biotech Hunter