Trial of Modifications to Radical Prostatectomy

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT01407263

Collaborator

(none)

2,600

Enrollment

Locations

Arms

144

Duration (Months)

866.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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."

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Lymph node template Procedure: Transverse versus vertical closure Drug: antibiotic prophylaxis	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2600 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Trial of Modifications to Radical Prostatectomy

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lymphadenectomy vs. no lymphadenectomy 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.	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.
Experimental: Transverse versus vertical closure of the port site incision (Closed as of 9/30/2021)	Procedure: Transverse versus vertical closure Transverse versus vertical closure of the port site incision
Experimental: One vs. three days of antibiotic prophylaxis (Closed as of 9/30/2021)	Drug: antibiotic prophylaxis One vs. three days of antibiotic prophylaxis at catheter removal

Arm

Intervention/Treatment

Experimental: Lymphadenectomy vs. no lymphadenectomy

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.

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.

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

Procedure: Transverse versus vertical closure

Transverse versus vertical closure of the port site incision

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

Drug: antibiotic prophylaxis

One vs. three days of antibiotic prophylaxis at catheter removal

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center at Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065