Trial Information

Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer

Radical cystoprostatectomy (RCP) is the standard treatment of muscle invasive, and
refractory high grade, superficial bladder cancer. RCP involves the removal of the bladder
and prostate. While this is an effective treatment for patients with organ confined disease
almost all men following RCP are impotent due to resection of the neurovascular bundles that
control erectile dysfunction. While neobladders (new bladders formed out of detubularized
bowel connected to the native urethra) allow patients to void normally, many of these
patients have difficulty with urinary incontinence. Two modifications have been developed to
improve the functional outcomes of this surgery. Nerve sparing cystectomy (NSC) attempts to
spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are
routinely divided during a standard RCP. Published series of NSC have shown improved
preservation of sexual function and less urinary incontinence without compromising cancer
control. Another alternative, prostate capsule sparing cystectomy (PCSC), removes the
adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the
prostatic capsule and subsequently the surrounding neurovascular bundle. Several
retrospective series have demonstrated preservation of sexual function and improved urinary
continence compared to standard RCP and neobladder. A concern with PCSC is that prostate or
urothelial cancer invading the prostate could be left behind with preservation of the
prostate capsule. Most reported series in which patients were screened with digital rectal
exam, prostate and prostatic urethral biopsy, and PSA blood testing could identify patients
at risk for having prostate or urothelial cancer in the prostate capsule preoperatively to
recommend an alternative approach. Therefore, both NSC and PCSC appear to offer better
urinary and sexual function in properly selected patients over conventional RCP in
retrospective series. However, these procedures have not been evaluated prospectively in a
randomized fashion. Our intent is to evaluate the functional outcomes of PCSC and NSC with
orthotopic neobladder in terms of urinary and sexual function using the bladder cancer
index, a validated quality of life instrument, and determine the surgical margin status, and
complications of the two surgical techniques.