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

NCT01824329 | Completed Phase 2 DMC

• 1 other identifier: HUM00000769
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bladder Cancer; Transitional Cell Carcinoma of the Bladder

Keywords

Bladder Cancer; Transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bladder cancer control

  7 years

• Sexual function

  7 Years

• Adverse event rates

  7 years

• Peri-operative differences

  7 years

Study Arms (2)

Prostate capsule sparing cystectomy Group

ACTIVE COMPARATOR

Prostate capsule sparing cystectomy involves removing the entire bladder.

Procedure: Prostate capsule sparing cystectomy

Nerve sparing cystectomy Group

ACTIVE COMPARATOR

Nerve sparing cystectomy involves removal of the whole bladder and the entire prostate.

Procedure: Nerve sparing cystectomy

Interventions

Prostate capsule sparing cystectomy PROCEDURE

Removes the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle.

Prostate capsule sparing cystectomy Group

Nerve sparing cystectomy PROCEDURE

Attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP.

Nerve sparing cystectomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Alon Weizer, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Urology

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: April 4, 2013
• Study Start: June 1, 2006
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

US (1)