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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 28, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date November 28, 2018
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2015)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)		 To compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomes [ Time Frame: 1 year ]
Continence outcomes will be taken from patient-reported outcomes questionnaires; however, if a patient-reported outcome is not available, then physician-reported outcomes will be used. Continence is defined as a binary endpoint of no pad use at one year.
Change History Complete list of historical versions of study NCT01407263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)		 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.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Modifications to Radical Prostatectomy
Official Title  ICMJE A Randomized Trial of Modifications to Radical Prostatectomy
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
  • Procedure: Transverse versus vertical closure
    Transverse versus vertical closure of the port site incision
  • Drug: antibiotic prophylaxis
    One vs. three days of antibiotic prophylaxis at catheter removal
Study Arms
  • 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.
    Intervention: Procedure: Lymph node template
  • Experimental: Transverse versus vertical closure of the port site incision
    Intervention: Procedure: Transverse versus vertical closure
  • Experimental: One vs. three days of antibiotic prophylaxis
    Intervention: Drug: antibiotic prophylaxis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)		 2300
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2011)		 1400
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Andrew Vickers, PhD 646-735-8142
Contact: Peter Scardino, MD 646-422-4329
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407263
Other Study ID Numbers  ICMJE 11-096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Vickers, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP