A Randomized Trial of Modifications to Radical Prostatectomy
21 Years
N/A
Male
Prostate Cancer
Trial Information
A Randomized Trial of Modifications to Radical Prostatectomy
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomes
Outcome Description:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Andrew Vickers, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
11-096
NCT ID:
NCT01407263
Start Date:
July 2011
Completion Date:
July 2021
Related Keywords:
- Prostate Cancer
- radical prostatectomy
- anastomotic suturing
- lymph node dissection
- 11-096
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Memorial Sloan-Kettering Cancer Center at Basking Ridge | Basking Ridge, New Jersey 07920 |
