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A Randomized Trial of Modifications to Radical Prostatectomy


Phase 3
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey  07920