Bladder Cancer Clinical Trial
— SPARCOfficial title:
Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Verified date | August 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative urinary function | 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). | 7 years | No |
Secondary | Bladder cancer control | Determine bladder cancer control with PCSC compared to NSC as measured by margin status and time to disease recurrence. | 7 years | No |
Secondary | Sexual function | Determine sexual function after PCSC and NSC using the BCI. | 7 Years | No |
Secondary | Adverse event rates | Determine adverse event rates after PCSC and NSC. | 7 years | Yes |
Secondary | Peri-operative differences | Determine peri-operative differences between PCSC and NSC in terms of operative time, estimated blood loss, length of hospital stay, and time to catheter removal. | 7 years | No |
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