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Trial of Modifications to Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT01407263
Recruitment Status : Recruiting
First Posted : August 2, 2011
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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 Drug: Hemostatic Agent Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2011
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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

Experimental: Hemostatic agent vs. no hemostatic agent 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.




Primary Outcome Measures :
  1. Patient-reported hernia [ Time Frame: 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 :
  1. To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [ Time Frame: 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.

  2. urinary tract infection (UTI) [ Time Frame: 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407263


Contacts
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Contact: Andrew Vickers, PhD 646-888-8233
Contact: Peter Scardino, MD 646-422-4329

Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrew Vickers, PhD    646-888-8233      
United States, New York
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Andrew Vickers, PhD    646-888-8233      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Vickers, PhD    646-888-8233      
Contact: Peter Scardino, MD    646-422-4329      
Principal Investigator: Andrew Vickers, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrew Vickers, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01407263    
Other Study ID Numbers: 11-096
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: March 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
radical prostatectomy
anastomotic suturing
lymph node dissection
11-096
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Anti-Bacterial Agents
Hemostatics
Anti-Infective Agents
Coagulants