Trial of Modifications to Radical Prostatectomy

Phase 3

Active, not recruiting

Interventions: Procedure: Transverse versus vertical closure
Drug: Hemostatic Agent
Procedure: Lymph node template
Drug: antibiotic prophylaxis

Brief 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."

Recruitment & Eligibility

Inclusion Criteria

Patients do not have to be eligible for both modifications to be included in the study.

Lymphadenectomy vs no lymphadenectomy:

Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC

Hemostatic agent vs. no hemostatic agent

Patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKC

Exclusion Criteria

Lymphadenectomy vs no lymphadenectomy

Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node >15mm in short axis on CT or MRI, a PSMA avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum)
Any prior pelvic radiation therapy used to treat prostate cancer

Hemostatic agent vs. no hemostatic agent

Arm && Interventions

Group	Intervention	Description
Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)	Transverse versus vertical closure	-
Hemostatic agent vs. no hemostatic agent	Hemostatic Agent	-
Lymphadenectomy vs. no lymphadenectomy	Lymph node template	In patients randomized to standard, only the nodal packet under the external iliac vein and above the obturator nerve will be dissected. For patients randomized to the modified template, the external iliac, hypogastric and obturator fossa nodal groups will be removed.No lymph nodes will be removed in patients randomized to the no PLND arm.
One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)	antibiotic prophylaxis	-

Primary Outcome Measures

Name	Time	Method
Patient-reported hernia	1 year	Patient-reported hernia is a routine assessment on post-operative questionnaires completed by prostate cancer patients at MSKCC. The questionnaire asks about hernia near the surgical scar and if there has been a need for surgical repair of the hernia.

Secondary Outcome Measures

Name	Time	Method
To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates	2 years	Biochemical recurrence is defined as any postoperative PSA of 0.2 ng / mL or higher, or treatment with hormones, radiotherapy or chemotherapy starting six months or more after radical prostatectomy.
urinary tract infection (UTI)	within 10 days	urinary tract infection (UTI) within 10 days of catheter removal. We will use the CDC's definition of UTI: symptomatic UTI diagnosed in patients with positive urine cultures (≥100,000 microorganisms per cm3) and at least one of the following signs or symptoms with no other recognized cause: fever (\>38oC), urgency, frequency, dysuria or suprapubic tenderness.50 UTI is routinely captured by clinical staff as a surgical complication.

Locations (5): Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
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Uniondale, New York, United States
Memorial Sloan Kettering Westchester
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Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
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New York, New York, United States
Memorial Sloan Kettering Bergen (Consent Only)
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Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
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Basking Ridge, New Jersey, United States