Prostate-Sparing Cystectomy for Bladder Cancer

Recruiting at 1 trial location

Overseen By Riziki' Covington

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Prostate cancer, Lynch syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prostate-Sparing Cystectomy for Bladder Cancer?

Prostate-sparing cystectomy for bladder cancer shows promising results, with similar cancer control to traditional methods and better functional outcomes, like improved continence and erectile function, especially in younger men. ^{1 2 3 4 5}

Is prostate-sparing cystectomy generally safe for humans?

Prostate-sparing cystectomy is considered a safe option for some patients with bladder cancer, as it may help preserve erectile function and urinary control. However, there are concerns about the risk of leaving behind cancerous tissue, so it is typically recommended for highly selected patients. ^{1 2 6 7 8}

How is prostate-sparing radical cystectomy different from other treatments for bladder cancer?

Prostate-sparing radical cystectomy (PSRC) is unique because it aims to preserve the prostate and surrounding nerves, potentially improving erectile function and urinary control compared to traditional radical cystectomy, which removes the prostate. ^{1 2 3 7 9}

Research Team

Armine Smith, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for men over 18 with bladder cancer who are scheduled for radical cystectomy, understand the study, and consent to participate. Men with prior pelvic radiation, Lynch syndrome, confirmed prostate cancer, moderate/severe erectile dysfunction (SHIM score <17), or increased genetic risk of prostate cancer aren't eligible.

Inclusion Criteria

My bladder cancer is of a specific, rare type.

Ability to understand and willingness to sign a written informed consent document

I have bladder cancer and am scheduled for complete bladder removal.

Exclusion Criteria

I have been diagnosed with prostate cancer.

My bladder cancer affects the bladder neck or prostate.

I have Lynch syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either prostate capsule-sparing or nerve-sparing radical cystectomy

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse events and functional outcomes, including erectile and urinary function

24 months

Every 3 months (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nerve sparing radical cystectomy
• Prostate capsule-sparing radical cystectomy

Trial Overview The trial compares two surgical methods: nerve-sparing and prostate capsule-sparing radical cystectomy. It aims to see if preserving the prostate capsule improves sexual and urinary functions without affecting cancer treatment outcomes.

Participant Groups

Group I: Prostate Capsule-Sparing Radical Cystectomy Experimental Treatment 1 Intervention

Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.

Group II: Nerve-Sparing Radical Cystectomy Experimental Treatment 1 Intervention

Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.

Nerve sparing radical cystectomy is already approved in European Union, United States, China for the following indications:

Approved in European Union as Nerve-sparing radical cystectomy for:

• Bladder cancer

Approved in United States as Nerve-sparing radical cystectomy for:

• Bladder cancer

Approved in China as Nerve-sparing radical cystectomy for:

• Bladder cancer

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

In a study of 40 patients with bladder cancer, both prostate capsule sparing and nerve sparing cystectomy techniques showed similar outcomes in urinary and sexual function after 12 months, indicating that either approach may be viable options.

There were no significant differences in cancer control measures, such as recurrence-free or overall survival rates, suggesting that both surgical techniques are equally effective in managing bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate capsule sparing versus nerve sparing radical cystectomy for bladder cancer: results of a randomized, controlled trial. Jacobs, BL., Daignault, S., Lee, CT., et al.[2021]

Prostate capsule sparing radical cystectomy (PSRC) may improve quality of life outcomes, such as erectile function and continence, compared to traditional cystoprostatectomy, although the evidence is based on limited and retrospective studies.

The local recurrence rate for PSRC is 5%, which is similar to that of standard cystoprostatectomy, and the overall survival rates are comparable, suggesting that PSRC is a viable option for selected patients with bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate capsule sparing radical cystectomy: oncologic safety and clinical outcome. Klotz, L.[2021]

Nerve sparing cystoprostatectomy (NSCP) and prostate capsule-sparing cystectomy (PCSC) show promising oncological outcomes, with 5-year cancer-specific survival rates of 90% for PCSC and 78% for NSCP after a median follow-up of 73 and 62 months, respectively.

PCSC resulted in significantly better functional recovery, with 90% of patients achieving full daytime urinary continence and 53% maintaining erectile function, compared to only 51% and 9% in the NSCP group, highlighting its advantages for patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term functional and oncological outcomes of nerve-sparing and prostate capsule-sparing cystectomy: a single-centre experience. Saad, M., Moschini, M., Stabile, A., et al.[2020]

In a study of 34 men undergoing prostate-sparing cystectomy (PSC) for bladder cancer, the procedure showed promising functional outcomes with 90% daytime and 85% night-time continence, and preserved potency in 29 patients.

However, the oncological outcomes were concerning, with a 21% recurrence rate and a notably high metastasis rate, suggesting that PSC may not be as effective as radical cystoprostatectomy for controlling bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostatic capsule- and seminal-sparing cystectomy for bladder carcinoma: initial results for selected patients. Botto, H., Sebe, P., Molinie, V., et al.[2019]

Prostate-sparing cystectomy offers similar cancer control as radical cystoprostatectomy while significantly improving functional outcomes, such as continence and erectile function, making it a promising option for selected patients.

With careful patient selection, including ruling out prostate invasion and significant prostate cancer, local and systemic relapse rates remain low (3% and 13%, respectively), indicating that this approach is both safe and effective for managing muscle-invasive bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of bladder cancer. Value of radical prostate-sparing cystectomy]. Heidenreich, A., Porres, D., Pfister, D.[2021]

In a study of 117 patients who underwent prostate sparing cystectomy for invasive bladder cancer, the long-term oncological outcomes showed a 5-year overall survival rate of 67% and a 5-year disease-free survival rate of 77% for patients with less advanced disease (pT2 N0 or less).

The study suggests that with careful patient selection and screening, the risk of significant prostate cancer is low, making prostate sparing cystectomy a valuable treatment option for selected patients wishing to avoid the functional side effects of traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological evaluation of prostate sparing cystectomy: the Montsouris long-term results. Rozet, F., Lesur, G., Cathelineau, X., et al.[2008]

Prostate sparing radical cystectomy (PSRC) shows a comparable local recurrence rate of 5% to the gold standard radical cystoprostatectomy (RCP), suggesting it may be a viable option for select patients with bladder cancer.

Current evidence on PSRC is limited and primarily retrospective, indicating that while short-term results are promising, more comprehensive studies are needed to firmly establish its long-term efficacy and safety compared to RCP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate sparing radical cystectomy--not for all, but an option for some. Pinthus, JH., Nam, RK., Klotz, LH.[2006]

In a study of 35 men undergoing radical cystoprostatectomy, 57% were found to have prostate cancer, highlighting a significant prevalence of cancer involvement in this patient group.

The study suggests that preoperative evaluations, including prostatic urethral and prostate biopsies, could help identify patients at risk for prostate cancer, which is crucial for determining eligibility for prostate capsule sparing cystectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the prostate peripheral zone/capsule in patients undergoing radical cystoprostatectomy: defining risk with prostate capsule sparing cystectomy. Weizer, AZ., Shah, RB., Lee, CT., et al.[2007]

Prostate-sparing radical cystectomy (PSRC) is a controversial treatment for bladder cancer, with limited experience and insufficient data on clear indications and contraindications, making it a complex option for patients.

While PSRC has the potential for excellent functional outcomes, its inconsistent oncological results highlight the need for careful patient selection and thorough patient education before considering this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-sparing radical cystectomy for selected patients with bladder cancer. Macek, P., Sanchez-Salas, R., Rozet, F., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prostate capsule sparing versus nerve sparing radical cystectomy for bladder cancer: results of a randomized, controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Prostate capsule sparing radical cystectomy: oncologic safety and clinical outcome. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Long-term functional and oncological outcomes of nerve-sparing and prostate capsule-sparing cystectomy: a single-centre experience. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Prostatic capsule- and seminal-sparing cystectomy for bladder carcinoma: initial results for selected patients. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of bladder cancer. Value of radical prostate-sparing cystectomy]. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Oncological evaluation of prostate sparing cystectomy: the Montsouris long-term results. [2008]

7. Canada pubmed.ncbi.nlm.nih.gov

Prostate sparing radical cystectomy--not for all, but an option for some. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the prostate peripheral zone/capsule in patients undergoing radical cystoprostatectomy: defining risk with prostate capsule sparing cystectomy. [2007]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate-sparing radical cystectomy for selected patients with bladder cancer. [2013]