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Trial of Modifications to Radical Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01407263
First received: July 29, 2011
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

This study aims to determine how different ways of performing prostate cancer surgery affect patient outcomes, such as recurrence of cancer or regaining control of bladder function (continence) after surgery. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is uncertainty about some methods of surgery.

All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to what is the best approach. This trial will evaluate whether the following two aspects of surgical technique influence outcome:

Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the body. However, there is uncertainty about which lymph nodes to remove (the "template"). In particular, not all surgeons think that it is important to remove a large number of lymph nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a result, these surgeons feel that removing additional lymph nodes does not improve the chance that a patient will be cured. In the study patients will either have the standard lymph node dissection or a modified approach.

Port site incision. Some surgeries are conducted with the help of what is called a surgical "robot", or using a laparoscopic approach (sometimes known as "keyhole" surgery). The surgeons have to make small cuts ("incisions") in order to insert their surgical instruments. Some surgeons believe that the way in which this cut is made can affect the chance that a patient will develop a hernia in the months after surgery. This is when tissues in the abdomen protrude through the incision, creating a small bulge that has to be surgically corrected. In the study, patients will either have the incision made vertically or horizontally.

Antibiotics. About a week after surgery, you will return to the hospital to have your catheter removed. To guard against the chance of infection, you will be given antibiotics. These do help prevent infection, but are also harmful. Doctors are unsure whether to give a short course of antibiotics or whether patients really need several days of treatment. In the study, patients will receive antibiotics for either one or three days.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Modifications to Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Patient-reported hernia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: within 10 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2300
Study Start Date: July 2011
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Transverse versus vertical closure of the port site incision Procedure: Transverse versus vertical closure
Transverse versus vertical closure of the port site incision
Experimental: One vs. three days of antibiotic prophylaxis Drug: antibiotic prophylaxis
One vs. three days of antibiotic prophylaxis at catheter removal

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders 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.

Template modification:

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

Antbiotic prophylaxis:

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

Port site closure technique:

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

Exclusion Criteria:

  • There are no exclusion criteria for any of the modifications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407263

Contacts
Contact: Andrew Vickers, PhD 646-735-8142
Contact: Peter Scardino, MD 646-422-4329

Locations
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrew Vickers, PhD    646-735-8142      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Vickers, PhD    646-735-8142      
Contact: Peter Scardino, MD    646-422-4329      
Principal Investigator: Andrew Vickers, PhD         
Memorial Sloan Kettering West Harrison Recruiting
West Harrison, New York, United States, 10604
Contact: Andrew Vickers, PhD    646-735-8142      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Andrew Vickers, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01407263     History of Changes
Other Study ID Numbers: 11-096 
Study First Received: July 29, 2011
Last Updated: July 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
radical prostatectomy
anastomotic suturing
lymph node dissection
11-096

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on September 30, 2016