Modifications to Radical Prostatectomy: Feasibility Study

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.