Intravesical Therapy vs Surgery for Bladder Cancer

(CISTO2 Trial)

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Intravesical agents

Disqualifiers: Plasmacytoid, Small cell, Cystectomy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 months

408 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two main treatment options for bladder cancer that hasn't spread to the muscle: therapies placed inside the bladder versus surgical removal of the bladder. Researchers aim to assess how these treatments impact patients' finances, health outcomes, and overall experiences. Suitable candidates for this trial have a history of bladder cancer that hasn't invaded the muscle and have undergone specific bladder treatments in the past year.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

Why are researchers excited about this trial?

Researchers are excited about comparing intravesical therapy and surgery for treating bladder cancer because it offers the potential to optimize treatment strategies. Intravesical therapy delivers medication directly into the bladder, potentially minimizing systemic side effects and targeting cancer cells more precisely. On the other hand, surgery, often the go-to for more advanced cases, can be invasive with longer recovery times. By evaluating these approaches side by side, researchers hope to determine which is more effective or beneficial for patients, potentially leading to more personalized treatment plans.

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

This trial will compare intravesical therapy with surgery for bladder cancer. Research has shown that treatments placed directly into the bladder, known as intravesical therapy, can be effective for bladder cancer. In one study, 50% of patients showed no signs of cancer after treatment, and 21% remained cancer-free after one year. A specific type of this treatment, called immunotherapy, can help reduce the chance of cancer returning and increase the number of patients who fully respond to treatment. However, 30-50% of patients might still experience a recurrence of cancer, even with these treatments. On the surgical side, a procedure called transurethral resection of bladder tumors has a 23.21% chance of cancer returning, but it also has an overall survival rate of 80.36%. Studies have also shown that some patients who only had surgery lived for many years. Both treatment options have their benefits, so discussing with a doctor is crucial to decide which is best for a specific situation. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I have paperwork confirming my diagnosis from a medical facility.

More than half of my cancer is urothelial carcinoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bladder sparing therapies or undergo bladder removal surgery

12 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 12 months post-enrollment

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4273309/

Intravesical Therapy for Urothelial Carcinoma of the ... Results showed that 50% of patients had a complete response and 21% were free of disease at one year (46).

2. sciencedirect.com sciencedirect.com/science/article/pii/S030228382500123X

A Systematic Review of Novel Intravesical Approaches for ... Unfortunately, 30–50% of patients will experience cancer recurrence despite intravesical therapies; consequently, new agents and approaches are required [2]. To ...

3. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2024.1309532/full

Outcomes of intravesical Bacillus Calmette-Guerin in ... Completion rate of induction BCG was 91%. Only 9% ceased treatment due to intolerance. The median duration of cystoscopy follow-up was 17 months ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2680547

Effect of Intravesical Instillation of Gemcitabine vs Saline ... Intravesical instillation of gemcitabine, compared with saline, significantly reduced the risk of recurrence over a median of 4.0 years.

5. cancerresearch.org cancerresearch.org/immunotherapy-by-cancer-type/bladder-cancer

Bladder Cancer - Cancer Research ... Immunotherapy has significantly reduced the risk of recurrence for bladder cancer while also increasing the percentage of patients who see a complete response ...