A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
This research study is for people with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC) that is considered intermediate risk. This means the cancer has not grown into the bladder muscle, and your doctor thinks it has a moderate chance of coming back. All participants will have surgery to remove the visible cancer. Half will then receive a new treatment called cretostimogene grenadenorepvec, given into the bladder, and half will be closely monitored. Doctors want to see if the new treatment can help prevent the cancer from returning compared to just monitoring. The study will track how well the treatments work and how safe they are.
At a glance
What is this study about?
This study is about a kind of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This means the cancer is only on the lining of the bladder and hasn't grown deeper into the muscle. If you have this type of cancer, doctors usually remove it with an operation called a TURBT. Even after surgery, this type of cancer can sometimes come back.
This study is looking at a new treatment called cretostimogene grenadenorepvec. It's a type of gene therapy designed to fight cancer cells. The study wants to find out if giving this new treatment after your surgery can stop the cancer from returning for longer compared to just keeping a close eye on you. They are focusing on patients whose cancer is considered 'intermediate risk', meaning it has a moderate chance of coming back.
By comparing these two approaches, researchers hope to see if cretostimogene grenadenorepvec could become a better way to treat this type of bladder cancer after surgery. This could potentially reduce the number of times patients need further treatments or operations in the future.
Key takeaways
- This study is for intermediate-risk non-muscle invasive bladder cancer (NMIBC).
- It compares a new treatment (cretostimogene grenadenorepvec) to watchful waiting after surgery.
- The new treatment is given into the bladder to try and stop cancer recurrence.
- Participation involves surgery, regular checks, and potentially the new treatment.
- You have a 50/50 chance of getting the new treatment or being monitored.
- The study aims to find a better way to prevent bladder cancer from returning.
Who may be eligible?
To join this study, you would need to have a specific type of bladder cancer called intermediate-risk non-muscle invasive bladder cancer (NMIBC). This means the cancer is only on the lining of your bladder and has certain features that put it at a moderate risk of coming back. You must have had surgery to remove all visible cancer within 90 days before joining the study, and your body's organs need to be working well.
You would not be able to join if your bladder cancer has grown into the muscle, has spread to other parts of your body, or is considered either very high risk or very low risk. Also, if you've had cancer in your prostate tube, or in the upper parts of your urinary system recently, or have received similar gene therapy treatments before, you wouldn't be able to take part.
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 intermediate-risk NMIBC?
- Has all my visible cancer been removed by surgery (TURBT) in the last 90 days?
- Am I at least 18 years old?
- Do my other body organs (like kidneys, liver) generally work well?
- Have I NOT had muscle-invasive, metastatic, or very high/low risk bladder cancer?
- Have I NOT received similar gene therapy treatments before?
What does participation involve?
If you decide to join this study, you would first have a surgical procedure called TURBT to remove your bladder cancer. Then, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the study treatment, cretostimogene grenadenorepvec, given directly into your bladder. This will start with an initial course, followed by maintenance treatments every three months for over a year, as long as your cancer hasn't returned. The other group will be closely monitored directly after your TURBT.
Regardless of your group, your医生 will regularly check for any cancer recurrence. This will involve checking your urine, looking inside your bladder with a camera (cystoscopy), and sometimes taking biopsies. These checks will happen every three months for the first two years, then every six months for another year. You'll also have scans, like a CT or MRI, every 12 months. If you are in the monitoring group and your cancer does return, you might then be offered the cretostimogene treatment. The total duration of active follow-up for the study could be several years.
Potential risks and benefits
Locations (95)
- Urology Centers of Alabama PCVerified postcodeHomewood, United States
- Banner MD Anderson Cancer CenterVerified postcodeGilbert, United States
- Mayo ClinicVerified postcodeScottsdale, United States
- Arizona Institute of Urology PLLCVerified postcodeTucson, United States
- Arkansas Urology PAVerified postcodeLittle Rock, United States
- Michael G. Oefelein MD Clinical TrialsVerified postcodeBakersfield, United States
- USC/Keck Department of UrologyVerified postcodeLos Angeles, United States
- Tower UrologyVerified postcodeLos Angeles, United States
- Sun Kim UrologyVerified postcodeOrange, United States
- University of California Irvine Medical Center (UCIMC)Verified postcodeOrange, United States
- University of California Davis Cancer CenterVerified postcodeSacramento, United States
- Stanford University School of MedicineVerified postcodeStanford, United States
Common questions
What is NMIBC?
NMIBC stands for Non-Muscle Invasive Bladder Cancer. This means the cancer is only on the inner lining of your bladder and hasn't grown into the muscle layer.
What does 'intermediate risk' mean?
Intermediate risk means your doctor thinks your bladder cancer has a moderate chance of coming back after surgery, based on its specific features.
What is TURBT?
TURBT is an operation (Transurethral Resection of Bladder Tumour) where a surgeon removes the visible bladder cancer using a special instrument passed through your urethra.
What is cretostimogene grenadenorepvec?
It's a new, investigational treatment being tested in this study. It's a type of gene therapy designed to target and fight cancer cells.
Will I definitely get the new treatment if I join?
No, because it's a 'randomised' study, you have a 50/50 chance of either receiving the new treatment or being closely monitored after your surgery.
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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