Status:
COMPLETED
Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Lead Sponsor:
University of Michigan
Conditions:
Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01824329
Start Date
June 1 2006
End Date
August 1 2014
Last Update
August 19 2015
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109