Description:
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.
Title
- Brief Title: Trial of Modifications to Radical Prostatectomy
- Official Title: A Randomized Trial of Modifications to Radical Prostatectomy
Clinical Trial IDs
- ORG STUDY ID:
11-096
- NCT ID:
NCT01407263
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| antibiotic prophylaxis | | One vs. three days of antibiotic prophylaxis |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Lymph node template | Experimental | 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. | |
| Transverse versus vertical closure of the port site incision | Experimental | | |
| One vs. three days of antibiotic prophylaxis | Experimental | | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 21 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Patient-reported hernia |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | 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. |
Secondary Outcome Measures
| Measure: | To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | urinary tract infection (UTI) |
| Time Frame: | within 10 days |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- radical prostatectomy
- anastomotic suturing
- lymph node dissection
- 11-096
Last Updated
July 8, 2021
