Trial of Modifications to Radical Prostatectomy

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Active, not recruiting

Phase 3

Conditions

Prostate Cancer

Treatments

Procedure: Transverse versus vertical closure

Drug: antibiotic prophylaxis

Procedure: Lymph node template

Drug: Hemostatic Agent

Study type

Interventional

Funder types

Other

Identifiers

NCT01407263

11-096

Details and patient eligibility

About

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."

Enrollment

3,204 patients

Sex

Male

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

No additional exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

3,204 participants in 4 patient groups

Lymphadenectomy vs. no lymphadenectomy

Experimental group

Description:

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.

Treatment:

Procedure: Lymph node template

Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)

Experimental group

Treatment:

Procedure: Transverse versus vertical closure

One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)

Experimental group

Treatment:

Drug: antibiotic prophylaxis

Hemostatic agent vs. no hemostatic agent

Experimental group