Modifications to Radical Prostatectomy: Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urethral irrigation but no fascial suturing, QOL forms<br>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<br>* 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<br>|
| Active Comparator: fascial suturing but no urethral irrigation, QOL forms<br>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<br>* 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<br>|
| Active Comparator: both urethral irrigation and fascial suturing, QOL forms<br> | Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms<br>* Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery<br>|
| Active Comparator: neither urethral irrigation nor fascial suturing, QOL forms<br> | Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms<br>* Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine surgeon compliance with allocation |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Radical Prostatectomy, urethral irrigation, fascial suturing, 09-051