Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments radical prostatectomy with urethral irrigation but no fascial suturing, qol forms, radical prostatectomy with fascial suturing but no urethral irrigation, qol forms, radical prostatectomy with both urethral irrigation and fascial suturing, qol forms, radical prostatectomy with neither urethral irrigation nor fascial suturing, qol forms
Sponsor Memorial Sloan Kettering Cancer Center
Start date June 2009
End date June 2017
Trial size 300 participants
Trial identifier NCT00928850, 09-051

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
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)
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.
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)
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)
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

Primary Outcomes

Measure
To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate
time frame: 1 year

Secondary Outcomes

Measure
Determine surgeon compliance with allocation
time frame: 1 year

Eligibility Criteria

Male participants at least 21 years old.

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.

Additional Information

Official title A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
Principal investigator Andrew Vickers, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.