A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low Grade (LG) Nonmuscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence (UTOPIA)
This study, called UTOPIA, is testing an experimental treatment called UGN-103 for adults with low-grade, non-muscle invasive bladder cancer. This type of cancer is on the inner lining of the bladder and has not grown into the deeper muscle layer. UGN-103 contains mitomycin, a well-known chemotherapy medicine, delivered as a special gel or liquid directly into the bladder through a small tube (catheter). Everyone taking part in this study receives the study treatment; there is no dummy treatment (placebo). Doctors will examine the bladder at three months using a small camera test (cystoscopy) and urine tests to see if all signs of cancer are gone. They will also track how long the treatment keeps the cancer away, monitor any side effects, and check how the treatment affects patients' daily quality of life.
At a glance
What is this study about?
Bladder cancer often starts in the inner lining of the bladder. When it has not spread into the deeper muscle wall, it is called non-muscle invasive bladder cancer. For many people, these tumours are low-grade, meaning they grow slowly, but they have a habit of coming back after treatment. Standard care usually involves regular hospital visits for minor surgery to scrape the tumours away, which can be uncomfortable and disruptive.
The UTOPIA clinical trial is testing a new treatment approach called UGN-103. UGN-103 uses a proven cancer-fighting drug called mitomycin, made into a special formula designed to stay in contact with the bladder wall for longer. The medicine is put straight into the bladder using a thin, flexible tube called a catheter, avoiding the need for general anaesthetic.
The main goal of this trial is to find out how effective UGN-103 is at completely clearing the tumours. Doctors also want to learn how safe the medicine is, how long any benefits last, and whether it helps people avoid repeated surgical procedures. If successful, this approach could offer an easier, less invasive treatment option for people living with this condition.
Key takeaways
- Testing a new liquid-gel medicine (UGN-103) placed directly into the bladder.
- Aims to treat low-grade bladder cancer without the need for standard surgery.
- All participants receive the study medicine; there is no placebo.
- A camera check at 3 months will see if the cancer has completely cleared.
- Participation is voluntary and you are monitored closely by cancer specialists.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with low-grade, non-muscle invasive bladder cancer that has an intermediate risk of returning. Both men and women can take part.
To join, your doctor must confirm that the cancer is only in the surface lining of your bladder and has not spread into the deeper muscle. You will also need to be well enough to receive treatment directly into your bladder and be able to attend regular hospital check-ups.
You may not be able to take part if your cancer has spread further, if you have high-grade (fast-growing) bladder cancer, or if you have certain other serious medical conditions. Your hospital doctor or study team can carry out tests to confirm if this trial is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with low-grade, non-muscle invasive bladder cancer.
- My cancer is at an intermediate risk of coming back.
- My cancer has not grown into the deeper muscle layer of the bladder.
- I am able to attend regular hospital appointments for bladder treatments and checks.
What does participation involve?
If you take part, a doctor or nurse will place the UGN-103 treatment directly into your bladder using a thin, flexible tube (catheter). The medicine is left inside the bladder for a set period before being naturally emptied out. This is usually done as a day procedure without needing an overnight hospital stay.
Three months after your first treatment, you will have a thorough check-up. This includes a cystoscopy (a quick look inside your bladder with a slender camera), urine tests, and a small tissue sample (biopsy) if needed, to see if the cancer has cleared.
If the cancer is gone, doctors will continue to check your bladder regularly over several months to see how long the treatment works. You will also have simple health checks, blood tests, and be asked to fill in short surveys about your symptoms and daily wellbeing. The study team will explain the exact visit schedule before you agree to join.
Potential risks and benefits
Locations (5)
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedLatvia
- —UnverifiedEstonia
Common questions
Will I receive a dummy treatment (placebo)?
No. This is a single-arm study, which means every patient who takes part will receive the active study medicine, UGN-103.
How is the medicine given?
The medicine is passed directly into your bladder through a soft, narrow tube called a catheter. It does not require surgery or a general anaesthetic.
What happens if the cancer comes back?
Your doctor will monitor you very closely. If the cancer does not go away or returns, you and your doctor can discuss standard treatment options, such as minor surgery.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any point. Deciding to withdraw will never affect your standard NHS care or your relationship with your medical team.
Does taking part cost anything?
No, the study medicine and all related tests are provided free of charge. In many trials, travel expenses for your hospital visits can also be reimbursed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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