Trial of Modifications to Radical Prostatectomy

Tracking Information
First Submitted Date ICMJE	July 29, 2011
First Posted Date ICMJE	August 2, 2011
Last Update Posted Date	November 29, 2017
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, Senior)
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 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP