Trial of Modifications to Radical Prostatectomy
Trial of Modifications to Radical Prostatectomy
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.
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

 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:

 Lymphadenectomy vs no lymphadenectomy

 -  Presence of positive/suspicious pelvic nodes on MRI or CT (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

 Port site closure technique:

 -  There are no exclusion criteria for any of the modifications