Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer (SPARC)

Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer; Transitional Cell Carcinoma of the Bladder
• Intervention / Treatment: Procedure: Prostate capsule sparing cystectomy; Procedure: Nerve sparing cystectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prostate capsule sparing cystectomy Group; Prostate capsule sparing cystectomy involves removing the entire bladder.	Procedure: Prostate capsule sparing cystectomy; Removes the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle.
Active Comparator: Nerve sparing cystectomy Group; Nerve sparing cystectomy involves removal of the whole bladder and the entire prostate.	Procedure: Nerve sparing cystectomy; Attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder cancer control	Determine bladder cancer control with PCSC compared to NSC as measured by margin status and time to disease recurrence.	7 years
Sexual function	Determine sexual function after PCSC and NSC using the BCI.	7 Years
Adverse event rates	Determine adverse event rates after PCSC and NSC.	7 years
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Alon Weizer, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 31, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Bladder Cancer; Transitional cell carcinoma of the bladder
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: HUM00000769