Bladder CancerPhase 2SPARCNCT01824329
Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
A Phase 2 study testing Prostate capsule sparing cystectomy and Nerve sparing cystectomy in people with Bladder Cancer and Transitional Cell Carcinoma of the Bladder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer, Transitional Cell Carcinoma of the Bladder
- What is being tested?
- Prostate capsule sparing cystectomy and Nerve sparing cystectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Prostate capsule sparing cystectomy, Nerve sparing cystectomy
- Keywords
- Bladder Cancer, Transitional cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate capsule sparing cystectomyProcedure or surgery
Removes the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle.
Nerve sparing cystectomyProcedure or surgery
Attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP.
| Study group | Role | What they receive |
|---|---|---|
| Prostate capsule sparing cystectomy Group | Active comparator | Prostate capsule sparing cystectomy involves removing the entire bladder. Receives: Procedure: Prostate capsule sparing cystectomy |
| Nerve sparing cystectomy Group | Active comparator | Nerve sparing cystectomy involves removal of the whole bladder and the entire prostate. Receives: Procedure: Nerve sparing cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 years
Secondary outcomes (4)
Bladder cancer control
Determine bladder cancer control with PCSC compared to NSC as measured by margin status and time to disease recurrence.
Measured: 7 years
Sexual function
Determine sexual function after PCSC and NSC using the BCI.
Measured: 7 Years
Adverse event rates
Determine adverse event rates after PCSC and NSC.
Measured: 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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJun 2006
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alon Weizer, University of Michigan
- Investigators
- Alon Weizer, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824329
- Sponsor's protocol ID
- HUM00000769
- Acronym
- SPARC
- Status last verified
- Aug 2015
- First submitted
- 31 Mar 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
- ClinicalTrials.gov ID
- NCT01824329
- Acronym / sponsor ID
- SPARC / HUM00000769
- Keywords
- Bladder Cancer, Transitional cell carcinoma of the bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate capsule sparing cystectomy Group | Active comparator | Procedure: Prostate capsule sparing cystectomyProstate capsule sparing cystectomy involves removing the entire bladder. |
| Nerve sparing cystectomy Group | Active comparator | Procedure: Nerve sparing cystectomyNerve sparing cystectomy involves removal of the whole bladder and the entire prostate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate capsule sparing cystectomyRemoves the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle. | Procedure or surgery | Prostate capsule sparing cystectomy Group |
| Nerve sparing cystectomyAttempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP. | Procedure or surgery | Nerve sparing cystectomy Group |
Primary outcome
Post-operative urinary function
Time frame: 7 years
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).
4 secondary outcomes
Bladder cancer control
Time frame: 7 years
Sexual function
Time frame: 7 Years
Adverse event rates
Time frame: 7 years
Peri-operative differences
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alon Weizer, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate capsule sparing cystectomy and Nerve sparing cystectomy in people with Bladder Cancer and Transitional Cell Carcinoma of the Bladder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative urinary function (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.