Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
18 Years
N/A
Male
Bladder Cancer, Transitional Cell Carcinoma of the Bladder
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.
Inclusion Criteria:
- Study subjects will be men 18 years or older
- histologic diagnosis of Ta - T2 transitional cell carcinoma within 3 months of
enrollment.
- no nodal or metastatic disease on pre-operative CT or MRI within 3 months of
enrollment.
- no evidence of malignancy in the prostate based on 12-core transrectal ultrasound
guided prostate needle biopsy and transurethral resection of prostatic urethra16
- candidate for and willingness to undergo a radical cystectomy and orthotopic
neobladder by the urologic surgeon performing the procedure.
- competent to provide informed consent
- able to read and write English
- willing to be randomized to PCSC versus NSC.
Exclusion Criteria:
- histologically proven stage T3 or greater bladder cancer and/or evidence of
metastatic disease by work-up described above.
- creatinine > 2.2 mg/dl.
- refuse to complete study requirements.
- prior pelvic radiation to bladder or prostate.
- history of radical prostatectomy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Post-operative urinary function
Outcome Description:
Assess post-operative urinary function using the bladder cancer index (BCI) in patients randomized to either prostate capsule sparing cystectomy (PCSC) or nerve sparing radical cystoprostatectomy (NSC).
Outcome Time Frame:
7 years
Safety Issue:
No
Principal Investigator
Alon Weizer, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan
Authority:
United States: Institutional Review Board
Study ID:
HUM00000769
NCT ID:
NCT01824329
Start Date:
June 2006
Completion Date:
Related Keywords:
- Bladder Cancer
- Transitional Cell Carcinoma of the Bladder
- Bladder Cancer
- Transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
