Cystoscopic Evaluation Before Surgery for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Prior pelvic irradiation, Pregnant, Nursing

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well cystoscopic evaluation, a procedure using a tiny camera to examine the bladder, can predict the stage of bladder cancer before surgery. The goal is to determine if some patients can avoid major surgery and retain their bladder. It targets individuals with bladder cancer who are planning to undergo a radical cystectomy, a surgery to remove the bladder. Those diagnosed with urothelial carcinoma and advised by their doctor to have bladder removal surgery might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to potentially avoid major surgery and preserve the bladder.

Do I need to stop my current medications for this trial?

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 this cystoscopic evaluation is safe for bladder cancer patients?

Research has shown that radical cystectomy, a surgery to remove the bladder, has been extensively studied. One study found that about 60% of patients experienced complications within 30 days after the surgery. The complication rate between 30 to 90 days post-surgery was around 72%. Although these numbers might seem high, they are typical for major surgeries.

Another study examined robotic-assisted radical cystectomy, a more advanced technique. This study found that robotic-assisted surgery is safe and does not increase the risk of complications compared to traditional surgery.

Overall, radical cystectomy is a well-known procedure. While complications can occur, these risks are normal for surgeries of this nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cystoscopic evaluation before surgery for bladder cancer because it offers a new way to assess the cancer's characteristics and extent before going straight to radical cystectomy, the typical treatment. Unlike the standard approach, which often moves directly to surgical removal of the bladder, this method allows doctors to gather more detailed information that could guide and potentially refine surgical planning. This could mean more tailored surgeries and possibly better outcomes for patients, as the procedure might help in deciding the extent of surgery needed. By providing a clearer picture of the cancer's spread, it aims to improve the precision and effectiveness of treatment decisions.

What evidence suggests that this cystoscopic evaluation is effective for predicting tumor stage in bladder cancer?

Research has shown that removing the bladder through surgery, known as radical cystectomy, effectively treats bladder cancer. Studies indicate that patients with muscle-invasive bladder cancer have better survival rates after this surgery. For instance, one study found that 81% of patients were alive and cancer-free five years post-surgery. Another study suggested that immediate surgery for early-stage bladder cancer can lead to better long-term outcomes. These findings suggest that radical cystectomy can be a strong option for treating bladder cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Alexander Kutikov, MD

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with urothelial carcinoma stages T1-T4NanyM0, who are fit enough for surgery (ECOG status 0-3), and have decided on radical cystectomy. They must understand the study and consent to participate. Women of childbearing age should agree to use contraception. Excluded are those with non-curative intent, prior pelvic radiation, or who are pregnant/nursing.

Inclusion Criteria

I can care for myself but may not be able to do active work.

I can understand and am willing to sign the consent forms myself or have someone who can do it for me.

I am over 18 years old.

Exclusion Criteria

I have not had a cystectomy that was not aimed at curing my condition.

I am not pregnant or nursing, as the treatment would be risky for a fetus or infant.

I have had radiation treatment to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Sample Collection

Collection of urine, PBMC, and serum/plasma samples prior to any chemotherapy administration and prior to the procedure

1 day

1 visit (in-person)

Procedure Day

Standard rigid cystourethroscopy and tissue sampling performed immediately prior to radical cystectomy

1 day

1 visit (in-person)

Post-Procedure Follow-up

Collection of urine, PBMC, and serum/plasma samples at 4-6 weeks and 6 months post-procedure to monitor genomic changes

6 months

2 visits (in-person)

Long-term Follow-up

Monitoring of genomic tumor signatures and chemotherapy response up to 5 years post-surgery

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Radical Cystectomy

Trial Overview The study tests how well a standardized cystoscopic evaluation with tissue sampling before radical cystectomy can predict tumor stage and identify candidates for bladder preservation therapy. It's prospective, meaning it follows patients forward in time from the point of their evaluation through surgery.

How Is the Trial Designed?

Group I: Surgical Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Published Research Related to This Trial

Hospital acquired adverse events occurred in 11.3% of patients undergoing radical cystectomy, significantly increasing the risk of in-hospital mortality (8.07 times higher) and leading to longer hospital stays (41.3% longer) and higher costs ($54,242 compared to $26,306).

Postoperative sepsis was particularly dangerous, associated with the highest mortality risk (17.56 times higher), a predicted length of stay increase of 62.22%, and the highest total hospitalization costs ($79,613), highlighting the need for improved patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implications of hospital acquired adverse events on mortality, length of stay and costs for patients undergoing radical cystectomy for bladder cancer. Kim, SP., Shah, ND., Karnes, RJ., et al.[2022]

In a study of 196 patients who underwent robot-assisted radical cystectomy (RARC) for bladder cancer, 80% experienced some form of complication within 90 days post-surgery, highlighting the significant morbidity associated with this procedure.

Major complications occurred in 35% of patients, with the most common issues being infections and gastrointestinal problems, indicating that while RARC is a minimally invasive option, it still carries substantial risks that need careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. Yuh, BE., Nazmy, M., Ruel, NH., et al.[2022]

Radical cystectomy (RC) has high rates of complications and mortality, prompting a focus on preoperative optimization strategies to improve patient outcomes.

Current literature suggests that comprehensive nutritional evaluation, supplementation, and prehabilitation may help reduce the risks associated with RC, beyond standard enhanced recovery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative optimization of the radical cystectomy patient: Current state and future directions. Ellis, JL., Dalimov, Z., Chew, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4024950/

Long-Term Oncologic Outcomes after Radical Cystectomy ... The 385 patients (54.9%) with pathologically organ-confined bladder tumors had excellent survival outcomes, whereas the patients with extravesical invasion or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790112/

Comparative Outcomes of Radical Cystectomy in Muscle ... This review underscores radical cystectomy's role in enhancing overall survival and reducing disease-specific mortality in muscle-invasive bladder cancer.

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00170-5/abstract

Radical cystectomy versus trimodality therapy for muscle ... 5-year cancer-specific survival for radical cystectomy versus trimodality therapy was 81% (95% CI 77–85) versus 84% (79–89) with IPTW and 83% ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214388224001334

Immediate cystectomy in T1 bladder cancer improves ... This study suggests that patients with T1 NMIBC who undergo immediate radical cystectomy have improved long-term cancer outcomes.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835469

Cost-Effectiveness of Trimodal Therapy and Radical ... This economic evaluation compares the cost-effectiveness of treatment and disease management strategies for muscle-invasive bladder cancer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37210247/

Survival outcomes in patients with muscle invasive bladder ... Results: A total of 22,534 patients met inclusion criteria, of which 6.9% (1,457) underwent PC. RC had longer median OS than PC (67.8 vs. 54.1 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143923001370

Survival outcomes in patients with muscle invasive bladder ... Among patients with clinically organ-confined MIBC, PC appears to afford similar survival outcomes to RC in a large national data set.

8. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1002/bco2.459

The feasibility and safety of robotic‐assisted salvage radical ... The 30-day and 30- to 90-day complication rates were not significantly different across the groups with rates of 60.53% and 71.71%, 73.68% and ...

9. journals.lww.com journals.lww.com/cur/fulltext/2025/07000/salvage_robotic_assisted_radical_cystectomy_is.10.aspx

Salvage robotic-assisted radical cystectomy is safe in... Here we present results of the first analysis to assess salvage robotic-assisted radical cystectomy (sRARC) with ICUD for bladder cancer, including both ileal ...