Trial of Modifications to Radical Prostatectomy
Conditions
Prostate Cancer
Conditions: Keywords
radical prostatectomy, anastomotic suturing, lymph node dissection, 11-096
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fascial suturing Type: Procedure
Name: Lymph node template Type: Procedure
Overall Status
Recruiting
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.

Fascial suturing. After surgery, patients can sometimes have long-term urinary incontinence. This is when a patient cannot control urine, and drips or leaks urine. Surgeons believe that what happens to the urethra (the tube that carries urine from the bladder to the penis) during surgery can affect the risk of incontinence. One idea is that additional stitches ("sutures") of the urethra to the connective tissue ("fascia") near the prostate during the surgery could be helpful, but this is not known for sure. In the study patients will either have the additional fascial suturing or no additional suturing.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Male
Criteria: Inclusion Criteria:

- Patients do not have to be eligible for both modifications to be included in the study.

Fascial suturing:

- Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.

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.

Exclusion Criteria:

Fascial suturing:

- No exclusion criteria.

Template modification:

- No exclusion criteria.
Locations
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Andrew Vickers, PhD - 646-735-8142
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Andrew Vickers, PhD - 646-735-8142
Start Date
July 2011
Completion Date
July 2021
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page