Clinical trial NCT00928850: Modifications to Radical Prostatectomy: Feasibility Study
Official title: A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Radical Prostatectomy
urethral irrigation
fascial suturing
09-051
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 154
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate
timeFrame: 1 year
Secondary outcomes:
measure: Determine surgeon compliance with allocation
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew Vickers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials. 2012 Feb 24;13:23. doi: 10.1186/1745-6215-13-23.