Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Completed · Phase 2
Conditions studied: Bladder Cancer, Transitional Cell Carcinoma of the Bladder
In brief
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.
Key facts
- Study ID
- NCT01824329
- Run by
- University of Michigan
- People needed
- 40
- Starts
- 2006-06-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2015-08-19
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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