Trial of Modifications to Radical Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 13, 2014
Last verified: August 2014

July 29, 2011
August 13, 2014
July 2011
July 2021   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01407263 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Trial of Modifications to Radical Prostatectomy
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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.
  • 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.
  • 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.
    Intervention: Procedure: Fascial suturing
  • 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.
    Intervention: Procedure: Lymph node template
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
July 2021
July 2021   (final data collection date for primary outcome measure)

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.
Male
21 Years and older
No
Contact: Andrew Vickers, PhD 646-735-8142
Contact: Peter Scardino, MD 646-422-4329
United States
 
NCT01407263
11-096
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Andrew Vickers, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP