Prostate-Sparing Cystectomy for Bladder Cancer

Recruiting at 2 trial locations

Overseen By Domani Rodriguez

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two bladder cancer surgeries to determine if sparing the prostate capsule can maintain better function without compromising cancer treatment results. Individuals with bladder cancer scheduled for bladder removal surgery might qualify for this trial. It compares two surgery types: prostate capsule-sparing radical cystectomy and nerve-sparing radical cystectomy. Participants will help researchers assess the impact on functions like urination and sexual health. Those with confirmed bladder cancer, without severe erectile dysfunction or prostate cancer, should consider joining this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance surgical outcomes for future patients.

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 prior data suggests that these surgical techniques are safe for patients?

Research has shown that prostate capsule-sparing radical cystectomy can improve nighttime bladder control and erectile function compared to traditional methods. Long-term studies are promising, showing a 93% cancer-specific survival rate at five years and 88.7% at ten years.

For nerve-sparing radical cystectomy, evidence indicates this method is safe, with outcomes similar to other procedures. No major differences in cancer recurrence or survival rates have been observed compared to traditional methods.

Both treatments are generally well-tolerated, with no major safety issues reported in the research. These findings suggest that both surgical options are relatively safe and aim to enhance quality of life without compromising cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prostate-sparing cystectomy techniques because they offer a promising approach to treating bladder cancer while preserving important prostate functions. Unlike standard radical cystectomies that remove the prostate, these techniques aim to spare nerve and prostate structures, potentially maintaining urinary control and sexual function. The prostate capsule-sparing radical cystectomy involves removing only the prostate's interior tissue, while the nerve-sparing radical cystectomy preserves the nerves crucial for erectile function. Both methods offer innovative ways to maintain quality of life for patients, which is a significant departure from traditional surgeries that do not focus on preserving these functions.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

This trial will compare prostate capsule-sparing radical cystectomy with nerve-sparing radical cystectomy. Research has shown that prostate capsule-sparing radical cystectomy may better preserve urinary function than nerve-sparing radical cystectomy. In one study, urinary function decreased by 13 points in the prostate capsule group, compared to a 28-point decrease in the nerve-sparing group. Long-term results from that study indicated that prostate capsule-sparing surgery had cancer-specific survival rates of 93% at 5 years and 88.7% at 10 years. Another study found that 88.6% of patients who underwent nerve-sparing surgery achieved complete daytime urinary control. Both treatments are considered safe and effective, with good survival rates and functional outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Armine Smith, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 am not a candidate for surgical removal of my bladder.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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-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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5730824/

Current status of laparoscopic and robot-assisted nerve ... [8] reported 35 patients underwent NS-CVP, and their functional outcomes showed that 88.6% patients could achieve complete daytime urinary continence, and 28.6% ...

2. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.652958/full

Perioperative and Pathological Outcome of Nerve-Sparing ... Our findings suggest that NS RC with OBS is a safe procedure. Perioperative and pathological outcome is comparable to the patients who received ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11710957/

Long-term Outcomes of Prostate Capsule-Sparing and ... This study aimed to compare and analyze the feasibility and long-term efficacy of prostatic capsule-sparing (PCS) and nerve-sparing (NS) radical cystectomy ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767323000320

Practice Patterns Regarding Female Reproductive Organ ... Female reproductive organ-sparing (ROS) and nerve-sparing radical cystectomy (RC) techniques have been shown to be oncologically safe and to improve sexual ...

5. e-juo.org e-juo.org/m/journal/view.php?doi=10.22465/kjuo.2018.16.1.32

DOI Five-year overall survival and cancer-specific survival were 86.7% and 86.7%, respectively, for nsRARC, and 77.7% and 86.7% for ORC. With ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9931545/

Oncological and functional outcomes of organ‐preserving ... The third study reported a significantly greater potency rate of 66.7% in prostate‐sparing cystectomy compared to 13.8% in nerve‐sparing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11639212/

Clinical efficacy and safety of organ-sparing cystectomy No significant differences were observed in recurrence rate, positive surgical margin rate, overall survival, and cancer-specific survival.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767321002172

Safety and Efficacy of Reproductive Organ-Sparing Radical ... In this analysis, ROS in women with advanced disease did not increase positive margin rates or decrease RFS, CSS, or OS compared to non-ROS.

9. einj.org einj.org/journal/view.php?id=10.5213/jkcs.2024.28.4.270

Long-term Outcomes of Prostate Capsule-Sparing and ... This study aimed to compare and analyze the feasibility and long-term efficacy of prostatic capsule-sparing (PCS) and nerve-sparing (NS) radical cystectomy in ...