Trial of Modifications to Radical Prostatectomy
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 11/30/2018 |
Start Date: | July 2011 |
End Date: | July 2021 |
Contact: | Andrew Vickers, PhD |
Phone: | 646-735-8142 |
A Randomized 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.
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.
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
We found this trial at
3
sites
136 Mountainview Blvd
Basking Ridge, New Jersey 7920
Basking Ridge, New Jersey 7920
(908) 542-3000
Phone: 646-735-8142
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 646-735-8142
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrew Vickers, PhD
Phone: 646-735-8142
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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