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Trial of Modifications to Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lymph node template

Transverse versus vertical closure

antibiotic prophylaxis

Hemostatic Agent

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring radical prostatectomy, anastomotic suturing, lymph node dissection, 11-096

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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

Sites / Locations

Memorial Sloan Kettering Cancer Center at Basking RidgeRecruiting
Memorial Sloan Kettering WestchesterRecruiting
Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Lymphadenectomy vs. no lymphadenectomy

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

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

Hemostatic agent vs. no hemostatic agent

Arm 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.

Outcomes

Primary Outcome Measures

Patient-reported hernia

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

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)

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.

Full Information

NCT ID

NCT01407263

First Posted

July 29, 2011

Last Updated

August 28, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01407263

Brief Title

Trial of Modifications to Radical Prostatectomy

Official Title

A Randomized Trial of Modifications to Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

radical prostatectomy, anastomotic suturing, lymph node dissection, 11-096

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lymphadenectomy vs. no lymphadenectomy

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Arm Title

Hemostatic agent vs. no hemostatic agent

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Lymph node template

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transverse versus vertical closure

Intervention Description

Transverse versus vertical closure of the port site incision

Intervention Type

Drug

Intervention Name(s)

antibiotic prophylaxis

Intervention Description

One vs. three days of antibiotic prophylaxis at catheter removal

Intervention Type

Drug

Intervention Name(s)

Hemostatic Agent

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient-reported hernia

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates

Description

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.

Time Frame

2 years

Title

urinary tract infection (UTI)

Description

Time Frame

within 10 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Vickers, PhD

Phone

646-888-8233

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Scardino, MD

Phone

646-422-4329

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Vickers, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center at Basking Ridge

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Vickers, PhD

Phone

646-888-8233

Facility Name

Memorial Sloan Kettering Westchester

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Vickers, PhD

Phone

646-888-8233

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Vickers, PhD

Phone

646-888-8233

First Name & Middle Initial & Last Name & Degree

Peter Scardino, MD

Phone

646-422-4329

First Name & Middle Initial & Last Name & Degree

Andrew Vickers, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33865797

Citation

Touijer KA, Sjoberg DD, Benfante N, Laudone VP, Ehdaie B, Eastham JA, Scardino PT, Vickers A. Limited versus Extended Pelvic Lymph Node Dissection for Prostate Cancer: A Randomized Clinical Trial. Eur Urol Oncol. 2021 Aug;4(4):532-539. doi: 10.1016/j.euo.2021.03.006. Epub 2021 Apr 15.

Results Reference

derived

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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Trial of Modifications to Radical Prostatectomy

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