Trial of Modifications to Radical Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01407263
First received: July 29, 2011
Last updated: February 13, 2014
Last verified: February 2014
  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.

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.


Condition Intervention Phase
Prostate Cancer
Procedure: Fascial suturing
Procedure: Lymph node template
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Modifications to Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Continence outcomes will be taken from patient-reported outcomes questionnaires; however, if a patient-reported outcome is not available, then physician-reported outcomes will be used. Continence is defined as a binary endpoint of no pad use at one year.


Secondary Outcome Measures:
  • To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1400
Study Start Date: July 2011
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fascial suturing
For patients randomized to either fascial suturing or no fascial suturing: after division of the dorsal venous complex and control of bleeding, the levator ani fibers are dissected away from the apex of the prostate exposing the urethra.
Procedure: Fascial suturing
Anastomotic suturing with and without inclusion of the fascia during a Radical Prostatectomy. Fascial suturing may aid return of continence by preventing hypermobility of the urethra.
Experimental: Lymph node template
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.
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407263

Contacts
Contact: Andrew Vickers, PhD 646-735-8142
Contact: Peter Scardino, MD 646-422-4329

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrew Vickers, PhD    646-735-8142      
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Vickers, PhD    646-735-8142      
Contact: Peter Scardino, MD    646-422-4329      
Principal Investigator: Andrew Vickers, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andrew Vickers, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01407263     History of Changes
Other Study ID Numbers: 11-096
Study First Received: July 29, 2011
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
radical prostatectomy
anastomotic suturing
lymph node dissection
11-096

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014