Spots Global Cancer Trial Database for Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer

Study Description

Brief Summary: Bladder cancer is the 4th most common cancer amongst men. If bladder cancer invades the muscle of the bladder or fails local treatments, surgical removal of the bladder (cystectomy) with creation of a new bladder from intestine is required. However, standard cystectomy affects urinary function and sexual function. The investigators are evaluating two modifications to cystectomy to determine to what extent they preserve urinary and sexual function.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

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