Active Surveillance vs Treatment for Bladder Cancer
(NEO-BLAST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if some bladder cancer patients can safely avoid bladder removal surgery after chemotherapy. Researchers will use advanced imaging, blood tests, and tissue samples to identify patients whose cancer might be entirely gone. Participants with no signs of cancer will be randomly assigned to either active monitoring (also known as active surveillance) or the usual bladder treatment, such as surgery or chemo-radiation. The trial seeks participants with muscle-invasive bladder cancer who are suitable for surgery or chemo-radiation, as assessed by a doctor.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in bladder cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have received any systemic therapy for urothelial carcinoma or certain other treatments within 2 years, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that for some patients, simply monitoring bladder cancer can be a safe choice. In one study, 67% of patients eventually needed more treatment, but 32% managed to stay on this watchful approach for over a year without further intervention. This indicates that while some patients required additional treatment, many could delay it for some time.
Another study found that monitoring small bladder tumors (less than 10 mm) posed low risk. This approach allows doctors to closely observe the cancer without immediately resorting to surgery or other treatments.
Overall, active surveillance involves regular check-ups, such as urine tests and scope exams, to monitor the bladder. It can be a well-tolerated option for certain patients, allowing them to avoid more aggressive treatments unless necessary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores active surveillance as an alternative to traditional treatments for bladder cancer. Unlike the standard of care, which typically involves radical cystectomy or chemo-radiation, active surveillance means patients are carefully monitored with cystoscopy, cytology, and imaging instead of undergoing immediate invasive procedures. This approach could potentially spare patients from the side effects and recovery time associated with surgery or radiation, while still effectively managing the disease. If successful, it may offer a less aggressive option for those with a clinical complete response, allowing them to maintain their quality of life.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that about 40% of bladder cancer patients have no remaining cancer after their first treatment. This suggests that some patients might avoid surgery if correctly identified. In this trial, participants who achieve a clinical complete response (cCR) may be randomized to an investigational arm of active surveillance, where researchers will monitor their cancer without immediate treatment. Studies have found that active surveillance is safe and effective for some bladder cancer cases. In certain groups, patients can safely avoid aggressive treatments and undergo regular monitoring instead. Advanced imaging and biological indicators, known as biomarkers, are being used to better identify those who might benefit from active surveillance. These tools aim to help select the right path for each patient, reducing unnecessary surgeries.13456
Who Is on the Research Team?
Peter Black, MD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for individuals with invasive bladder cancer who have completed initial systemic treatment. It aims to identify those without remaining cancer using advanced imaging, biopsies, and tumor DNA detection in blood/urine. Participants must be eligible for randomization to active surveillance or conventional treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Therapy
Participants receive standard of care neoadjuvant therapy (NAT) for muscle-invasive bladder cancer
Clinical Restaging
Participants undergo clinical restaging to assess complete clinical response (cCR) using ctDNA, MRI, and bladder biopsies
Randomization and Treatment
Participants with cCR are randomized to active surveillance or definitive bladder treatment (radical cystectomy or chemo-radiation)
Follow-up
Participants are monitored for safety and effectiveness after treatment with regular cystoscopy, cytology, and imaging
What Are the Treatments Tested in This Trial?
Interventions
- Active Surveillance
- Definitive bladder treatment
Trial Overview
The NEO-BLAST study tests whether patients with no evidence of bladder cancer after chemotherapy can safely undergo active surveillance instead of immediate definitive bladder treatment (removal or chemo-radiation). This pilot RCT will use MRI, biopsies, and biomarkers for decision-making.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants found to have a clinical complete response following NAT randomized to the investigational arm consisting of active surveillance. They will have have no local treatment to their bladder and will be monitored with cystoscopy, cytology and imaging (active surveillance)
Participants found to have residual urothelial carcinoma (not cCR) will received the standard of care definitive bladder treatment. They will received either radical cystectomy or chemo-radiation of the bladder.
Participants found to have a clinical complete response following NAT randomized to standard of care, described as "definitive bladder treatment", which consists of either radical cystectomy, or chemo-radiation of the bladder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Peter Black
Lead Sponsor
University of British Columbia
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Published Research Related to This Trial
Citations
Active Surveillance in Non-Muscle Invasive Bladder Cancer
In this study, we reviewed the results of several previous studies to understand how safe and effective active surveillance is for patients ...
When and How To Perform Active Surveillance for Low-risk ...
The study found that cystoscopy alone was able to correctly predict the low-grade nature of 86% of the tumors without the support of urine ...
Long-term oncological outcomes of an active surveillance ...
Conclusions. AS in a high-selectivity group of patients with recurrent non−muscle-invasive bladder tumor is feasible and oncologically safe in the long term.
Active Surveillance vs Treatment for Bladder Cancer
Research shows that approximately 40% of patient will have no remaining cancer left in their bladder after completion of the initial systemic treatment, and ...
Active Surveillance in Non-Muscle Invasive Bladder ...
In the main results of this study, the probability of active treatment absence was 59.7%, 54.5%, 46.3%, and 40.4% at 12, 18, 24, and 36 months, ...
Active surveillance for non-muscle invasive bladder cancer
AS failure rate was 67% (95%CI 44–84%) and 32% of pts were still on AS (14–56%) during a median AS time of 15,6 months.
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