Modifications to Radical Prostatectomy: Feasibility Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00928850
First received: June 25, 2009
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. 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 disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.

Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.

All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.

Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.

Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.


Condition Intervention
Prostate Cancer
Procedure: radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms
Procedure: radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms
Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms
Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine surgeon compliance with allocation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: urethral irrigation but no fascial suturing, QOL forms
The anterior two-thirds of the urethra is divided exposing a Foley catheter that was placed at the beginning of the procedure. Irrigation of the urethra may prevent spread of prostate cancer cells to tissue that is not removed during surgery. The urethra is irrigated with 60 cc of sterile water as it is withdrawn from the patient to 'wash' the urethra.
Procedure: radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms
Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Active Comparator: fascial suturing but no urethral irrigation, QOL forms
For patients undergoing fascial suturing only, after the initial placement of the suture through the urethra a second bite is taken deeply into the fascia of the lateral pelvic fascia.
Procedure: radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms
Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Active Comparator: both urethral irrigation and fascial suturing, QOL forms Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Active Comparator: neither urethral irrigation nor fascial suturing, QOL forms Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.

Exclusion Criteria:

  • Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928850

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andrew Vickers, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00928850     History of Changes
Other Study ID Numbers: 09-051
Study First Received: June 25, 2009
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate
Radical Prostatectomy
urethral irrigation
fascial suturing
09-051

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 April 17, 2014