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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01407263
Other study ID # 11-096
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 2011
Est. completion date July 2021

Study information

Verified date November 2018
Source Memorial Sloan Kettering Cancer Center
Contact Andrew Vickers, PhD
Phone 646-735-8142
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2300
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender Male
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center at Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary 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. 2 years
Secondary 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. within 10 days
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