Radical Cystectomy for Bladder Cancer

(CONSOLIdATE-1 Trial)

Overseen By Laura Kane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Enfortumab vedotin

Disqualifiers: Pregnancy, Breastfeeding, CNS metastasis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests radical cystectomy, a surgery that removes the bladder, to determine its benefits for people with a specific type of bladder cancer. It targets individuals with locally advanced urothelial carcinoma or a few metastatic sites who have responded well to a specific drug treatment. The goal is to assess whether adding this surgery can further control the disease. Ideal participants have bladder cancer that has spread to five or fewer sites and have shown stability or improvement with prior treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received systemic anti-cancer therapy within three weeks prior to the surgery.

What prior data suggests that radical cystectomy is safe for bladder cancer patients?

Research has shown that radical cystectomy, a surgery to remove the bladder, is generally safe for bladder cancer patients. Studies examining long-term outcomes have found that many patients experience good survival rates after the surgery. Specifically, one study found that over 50% of patients lived at least five years post-procedure.

Another study demonstrated that robotic-assisted radical cystectomy, which uses robotic tools, is also safe for these patients. This indicates that both traditional and robotic surgeries are well-tolerated.

While these studies suggest the surgery is generally safe, all surgeries carry risks. Discussing with a doctor can help determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about radical cystectomy for bladder cancer because it offers a comprehensive surgical approach that goes beyond standard treatments. Unlike typical bladder cancer therapies, which may involve partial surgeries or chemotherapy, this treatment involves a radical cystectomy paired with a bilateral pelvic lymph node dissection and possibly a metastasectomy. This means not only removing the bladder but also addressing lymph nodes and any resectable metastatic disease, potentially improving patient outcomes. The option for either open or robotic surgery provides flexibility to tailor the approach to individual patient needs, which could enhance recovery and effectiveness.

What evidence suggests that radical cystectomy is effective for bladder cancer?

Research has shown that removing the bladder through surgery, known as radical cystectomy, can lead to good survival rates for patients with invasive bladder cancer. Studies have found that this procedure links to positive long-term outcomes. However, some patients may experience cancer recurrence after surgery. If the cancer spreads to distant parts of the body, survival rates generally decrease. Despite this, radical cystectomy remains an important treatment option for advanced bladder cancer, especially when combined with other treatments like chemotherapy or radiation. ^{2 3 6 7 8}

Who Is on the Research Team?

Fed Ghali, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with advanced or oligo-metastatic urothelial carcinoma who've had some control over their disease using enfortumab vedotin therapy and can undergo surgery. They should have good organ function, an ECOG status of 0 or 1, and no more than five metastatic lesions at diagnosis. Pregnant women, those breastfeeding, or individuals with conditions that could interfere with the study are excluded.

Inclusion Criteria

My surgeon agrees I can have surgery to remove cancer that hasn't been treated with radiation.

I am 18 years old or older.

My cancer is mostly urothelial and less than half is a different type.

Exclusion Criteria

Have a positive serum pregnancy test or women who are breastfeeding

Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations

I have had cancer treatment within the last 3 weeks before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Systemic Therapy

Participants receive enfortumab vedotin-based systemic therapy to achieve disease control

Varies based on individual response

Consolidative Local Therapy

Participants undergo radical cystectomy with bilateral pelvic lymph node dissection and metastasectomy

Surgical intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and progression-free survival post-surgery

12 months

Visits at 30, 90, 180, 270, and 365 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Radical Cystectomy

Trial Overview The trial tests if removing all visible cancer through surgery (radical cystectomy) after initial success with drug therapy helps patients live longer without their cancer spreading. It's for those whose scans show stable disease or better after first-line treatment and includes metastasis-directed radiotherapy as recommended.

How Is the Trial Designed?

Group I: Radical cystectomy Experimental Treatment 1 Intervention

The intervention in this clinical trial consists of definitive surgical management through radical cystectomy with bilateral pelvic lymph node dissection (PLND), urinary diversion, and metastasectomy of surgically resectable or previously radiated metastatic disease. Surgical approach may be either open or robotic, based on surgeon discretion and patient-specific factors. The PLND will be performed in a standard oncologic fashion, including dissection of the common iliac, external iliac, internal iliac, and obturator nodal basins bilaterally. In cases where metastatic lymph nodes are identified beyond these regions, the lymph node dissection may be extended to achieve gross resection of involved nodal disease within the abdomen or retroperitoneum.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Medical College of Virginia Foundation

Collaborator

Citations

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

Long-Term Oncologic Outcomes after Radical Cystectomy ... Radical cystectomy provides good survival results in patients with invasive bladder cancer. Pathologic features significantly associated with prognosis include ...

2. e-juo.org e-juo.org/journal/view.php?number=558

Clinical Outcomes of Patients With Variant Histology ... Our study evaluated the clinical outcomes and survival expectancies of post-cystectomy patients with VH based on their stratified risk profile.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666168321001014

Outcomes for Muscle-invasive Bladder Cancer with ... Previous studies have shown that rates of salvage cystectomy in patients with TMT range from 10.7% to 14.7% [5], [20]. Interestingly, in our study, we observed ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.574

Oncologic outcomes following post-cystectomy recurrence ... For distant recurrence alone, only 33% survived past the first year. Salvage immunotherapy was administered in 8% of the patients and 47% ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000002242

Management Trends and Outcomes of Patients ... Median followup was 10.1 years (range, 3 months to 40.4 years), during which 1,038 (31%) patients recurred and 1,900 (56.8%) patients died.

6. nature.com nature.com/articles/s41598-018-26089-x

Oncological outcomes, quality of life ... Estimated 5-year overall- and progression-free survival rates were 53.7% and 62.1%. Five (18.5%) patients experienced local recurrence with MIBC ...

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. 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 ...