A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
This study is looking into a new treatment called TAR-200 for a specific type of bladder cancer. This cancer is called 'high-risk non-muscle-invasive bladder cancer' and it has come back within a year after a common treatment called BCG. The study aims to see if TAR-200 is better at preventing the cancer from returning compared to standard chemotherapy given directly into the bladder. It's for people who have been advised against, or have chosen not to have, major surgery to remove their bladder (radical cystectomy). Researchers want to find out if TAR-200 can offer a new and effective option for these patients.
At a glance
What is this study about?
This research study is about a type of bladder cancer called 'high-risk non-muscle-invasive bladder cancer' (HR-NMIBC). This means the cancer is serious but hasn't grown into the deeper muscle layers of the bladder. People in this study have had their cancer come back within a year after a common treatment called Bacillus Calmette-Guérin (BCG).
The main goal of this study is to compare a new treatment, TAR-200, with standard chemotherapy given directly into the bladder. Doctors want to see which treatment is better at keeping the cancer from coming back. This study is specifically for people who either can't have, or have decided not to have, a major operation to remove their bladder, which is called a radical cystectomy.
By taking part, you could help doctors learn more about how to treat this bladder cancer. Finding new ways to manage this condition is very important, especially for people who want to avoid or can't have major surgery.
Key takeaways
- This study compares a new treatment (TAR-200) with standard chemotherapy for a specific type of bladder cancer.
- It's for bladder cancer that has returned after BCG treatment and hasn't spread into the bladder muscle.
- The study is for people who cannot or choose not to have surgery to remove their bladder.
- Its main goal is to find out if TAR-200 is better at preventing the cancer from coming back.
- Participation could help improve future treatments for bladder cancer patients.
Who may be eligible?
To join this study, you would need to have a specific type of bladder cancer called high-risk non-muscle-invasive bladder cancer that has come back. This cancer must only be in the surface layers of the bladder and not have spread into the muscle. You must also have chosen not to have, or be unable to have, surgery to remove your bladder. You should generally be well enough to carry out most of your daily activities.
There are also some reasons why you might not be able to join. For example, if your cancer has spread into the bladder muscle or elsewhere in your body. Also, if you have another type of bladder cancer called carcinoma in situ (CIS) at the time of screening. If your doctor thinks that the special device for TAR-200 can't be safely placed or stay in your bladder, or if you have a history of making a lot of urine, you might also not be able to participate. You also can't have had TAR-200 treatment before.
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.
- Have I been diagnosed with high-risk, non-muscle-invasive bladder cancer that has returned?
- Did my bladder cancer come back within a year after my last BCG treatment?
- Has my doctor told me that I can't have, or have I decided not to have, bladder removal surgery (radical cystectomy)?
- Am I generally well enough to do most of my usual daily activities?
- Do I only have cancer on the surface of my bladder, not in the muscle or other parts of my body?
- Have I not received TAR-200 treatment in the past?
What does participation involve?
If you decide to take part in this study, you would receive either the new treatment, TAR-200, or one of the standard chemotherapy treatments (Mitomycin C or Gemcitabine) directly into your bladder. The specific details of visits and treatment schedule would be explained by the study team, as it varies depending on which treatment group you are in. You would have regular check-ups, which include tests to see how the treatment is working and to monitor your general health. This might involve urine tests, bladder inspections, and other assessments. The study will follow you to see how long you remain free of cancer. The total duration of your participation, including follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (123)
- Arkansas UrologyVerified postcodeLittle Rock, United States
- Genesis Research LLC 1Verified postcodeLos Alamitos, United States
- USC Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States
- University of California Irvine Medical CenterVerified postcodeOrange, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Genesis Research LLCVerified postcodeTorrance, United States
- Colorado Clinical ResearchVerified postcodeLakewood, United States
- Florida Urology PartnersVerified postcodeRiverview, United States
- Northwestern UniversityVerified postcodeChicago, United States
- UroPartnersVerified postcodeChicago Ridge, United States
- Urology of IndianaVerified postcodeCarmel, United States
- First Urology, PSCVerified postcodeJeffersonville, United States
Common questions
What is 'non-muscle-invasive bladder cancer'?
This is bladder cancer that is found only in the inner lining of the bladder and hasn't spread into the deeper muscle layers.
What is BCG?
BCG is a medicine, given directly into the bladder, often used to treat and prevent early-stage bladder cancer from coming back.
What is 'radical cystectomy'?
This is a major surgery to completely remove the bladder. This study is for people who can't or won't have this operation.
What is TAR-200?
TAR-200 is a new treatment being studied for bladder cancer. It's designed to deliver medicine directly into the bladder over time.
What are 'intravesical chemotherapy' treatments?
These are chemotherapy medicines like Mitomycin C or Gemcitabine that are put directly into the bladder as a liquid.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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