A Study of Intra-operative Autologous Retropubic Urethral Sling on Urinary Control After Robot Assisted Radical Prostatectomy

This is a phase 2 single blinded study of patients undergoing robot assisted radical
prostatectomy who are randomized to placement of an autologous retropubic urethral sling or
not. Placement of a retropubic urethral sling will involve dissection and harvesting of the
right and left vas deferens, which will be taken out of the body by the bed side assistant
who will suture the two vas deferens together in a side to side fashion with the smaller of
the two vas deferens placed in the middle of the larger one. A single 3-0 V-lock suture on a
CV23 needle will be placed through one end of the vas sling and then passed into the body by
the bed side assistant. The sling will then be placed on the rectum below the site of the
vesicourethral anastamosis and the anastamosis will be completed. The sling will then be
placed around the vesicourethral anastomosis, suspended to the pubic symphysis and tensioned
to allow elevation of the vesicourethral anastomosis. There are four surgeons working at
both trial sites who will be involved in performing the radical prostatectomy and sling
placement on trial patients. All surgeons have had significant experience in performing
radical prostatectomy (> 100 cases each). To ensure sufficient experience in the placement
of urethral slings, each surgeon (other than the principle investigator, who has placed over
200 slings) will undergo a training period of 5 patients with sling placement under the
proctoring of the principal investigator prior to accrual of the first trial patient from
the individual surgeon. All patients will be characterized with respect to age, ethnicity,
BMI, prostate size, amount of nerve sparing, preoperative urinary function, surgeon, serum
PSA, and tumor characteristics. Prostate size and tumor characteristics will be attained at
histological assessment of the prostate specimen by the pathology department. Preoperative
urinary function will be assessed by EPIC and IPSS questionnaires at baseline. The amount of
nerve sparing will be assessed by the surgeon performing the radical prostatectomy after the
prostate dissection is complete. Each side will be assessed separately as complete, partial
or no nerve sparing. Stratification will be based upon age at enrollment (<65 years vs. >65
years). For each of the 2 strata patients will be randomized to placement of a sling or not,
serving as the control group, on a one to one basis with the assignment determined using a
computer software program. Randomization assignment of the planned procedure will be
balanced using a fixed block design. Consecutively identified patients undergoing RARP and
meeting eligibility criteria for the trial will be approached for involvement in this trial.
Patients and study personnel will be blinded as to which patients received slings. Surgeons
performing the individual procedures cannot be blinded to the procedure, but will not know
the randomization assignment until the prostate dissection is completed and the procedure
reaches the stage of sling placement. A sealed envelope containing the randomization
assignment of the patient to the sling or non-sling group will be placed at the operating
room front desk by the research coordinator prior to the start of surgery. This envelope
will not be opened until the prostate is removed. A unique identifying number, that has no
association with randomization allocation, will be assigned to each trial patient. These
numbers will be placed on envelopes to match them to patients to avoid any confusion on days
where multiple trial patients may be undergoing radical prostatectomy. Furthermore, surgeons
will not be involved in attaining any outcome data from patients and therefore should not
cause any bias to the study outcomes. Investigators expect accrual of 5 patients every week;
therefore, investigators estimate that it will take approximately 37 weeks to complete the
study accrual of 182 evaluable patients.

Inclusion Criteria:

- Newly diagnosed patients undergoing robot assisted radical prostatectomy at UCSF

- Histologically defined adenocarcinoma of the prostate

- English or Spanish speaking patients with the ability to provide informed written
consent and willingness to comply with the requirements of the protocol

- Age 40-75 year

Exclusion Criteria:

- · Patients should not have received any radiation or hormonal therapy prior to
surgery for any purpose

- Any prior prostate surgery

- No current or previous history of urinary incontinence requiring chronic pad use
or treatments for urinary incontinence

- Patients may not be receiving any other investigational agents

- Any condition that compromises compliance with the objectives and procedures of
this protocol, as judged by the principal investigator