TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This research, called TulmiSTAR-02, is for men with metastatic hormone-sensitive prostate cancer (mHSPC) – meaning the cancer has spread but still responds to hormone therapy. The study is divided into two main parts. First, it tests different doses of a new drug called tulmimetostat when given with either darolutamide or abiraterone, to find the safest and most effective amount. Next, it compares one of these combinations (tulmimetostat plus darolutamide) against darolutamide alone, to see if adding tulmimetostat improves treatment. Researchers want to understand if these new combinations are safe, can be tolerated, and if they can help men with mHSPC. It's about finding promising new options.
At a glance
What is this study about?
This study, called TulmiSTAR-02, is for men who have prostate cancer that has spread to other parts of their body (metastatic) but still responds to hormone treatment (hormone-sensitive). This type of cancer is often treated by lowering testosterone levels in the body. The study is looking at a new drug called tulmimetostat and how it works when combined with two other established prostate cancer medicines: darolutamide and abiraterone.
The study has two main steps. In the first step (Phase I), a small number of men will receive tulmimetostat along with either darolutamide or abiraterone. The main goal here is to carefully find the right dose of tulmimetostat when used with each of these drugs. This is important to make sure the treatment is as safe as possible while still being effective. Men in this part of the study will continue their usual hormone treatment to keep their testosterone levels low.
Once the best doses are found, the study moves to the second step (Phase II). Here, more men will be randomly assigned to one of two groups: one group will receive tulmimetostat combined with darolutamide, and the other group will receive darolutamide alone. This allows the researchers to compare the new combination with a standard treatment to see if adding tulmimetostat makes a difference in terms of safety and how well it treats the cancer. The overall aim is to explore if these new drug pairings could offer beneficial new ways to treat metastatic hormone-sensitive prostate cancer.
Key takeaways
- This study is for men with prostate cancer that has spread and still responds to hormone treatment.
- It tests a new drug, tulmimetostat, in combination with existing treatments (darolutamide or abiraterone).
- The study aims to find safe and effective doses, and to see if the new combinations work better.
- Participation involves screening, receiving treatment, and long-term follow-up.
- You will be closely monitored by doctors throughout your involvement.
- Your decision to join or leave the study is entirely yours, without affecting your care.
Who may be eligible?
This study is looking for adult men aged 18 or older who have prostate cancer that has spread to other parts of the body and still responds to hormone treatment. You would need to have already started hormone therapy within the last year and be willing to continue receiving it throughout the study. Your testosterone levels must also be low enough, as a result of your hormone therapy.
You might still be able to join if you've had certain other treatments in the past. For example, if you've had a type of chemotherapy called taxane, or another hormone-blocking medicine (ARPI), you might be eligible, but there are specific rules about when and how you received these treatments. The study is carefully designed to include men who will benefit most and be safest within the trial.
There are also some general health requirements, such as good organ function, which the study team will check. If you are currently taking darolutamide, you would not be able to join the part of the study that compares different treatments, but your doctor can check if you might be suitable for other parts if your current treatment isn't working as well as it could.
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.
- Are you an adult man (18 years or older)?
- Do you have prostate cancer that has spread (metastatic) and is 'hormone-sensitive'?
- Have you been on hormone therapy for your prostate cancer for at least one month but no more than 12 months, and are you willing to continue it?
- Do you have suitable general health and organ function (this will be checked by the study team)?
- Have you been previously treated with darolutamide, or other specific ARPIs, and does your doctor think you might benefit from switching or adding treatments?
What does participation involve?
If you decide to take part in this study, your journey will typically involve three stages. First, there's a 'screening period', where you'll have tests to check if the study is right for you. This usually involves blood tests, scans, and physical exams to understand your current health and cancer status.
Next is the 'study treatment period'. During this time, you will receive the assigned study medications (tulmimetostat, darolutamide, or abiraterone, along with your regular hormone therapy). You'll have regular visits to the clinic for check-ups, blood tests, and to make sure the treatment is safe and tolerable. The number of visits and tests will depend on your specific treatment plan, but the team will monitor you closely.
After your treatment period ends, there's a 'long-term follow-up' stage. This means the doctors will keep in touch to check on your health and how you're doing in the long run. The total length of your involvement in the study, from screening to long-term follow-up, will vary, but the study team will explain all the details before you start.
Potential risks and benefits
Locations (30)
- Uni Of Iowa Hospitals And ClinicsVerified postcodeIowa City, United States· Recruiting
- University of Kansas Cancer CenterVerified postcodeWestwood, United States· Recruiting
- Wichita Urology Group PAVerified postcodeWichita, United States· Recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Recruiting
- Medical University of South Carolina MUSCVerified postcodeCharleston, United States· Recruiting
- Carolina Urologic Research CenterVerified postcodeMyrtle Beach, United States· Recruiting
- Huntsman Cancer InstituteVerified postcodeSalt Lake City, United States· Recruiting
- Novartis Investigative SiteVerified postcodeCamperdown, Australia· Withdrawn
- Novartis Investigative SiteVerified postcodeWollongong, Australia· Recruiting
- Novartis Investigative SiteVerified postcodePorto Alegre, Brazil· Recruiting
- Novartis Investigative SiteVerified postcodeMontreal, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeGuangzhou, China· Recruiting
Common questions
What is 'metastatic hormone-sensitive prostate cancer'?
This means your prostate cancer has spread to other parts of your body, but it still responds to treatments that lower male hormones like testosterone.
What is a 'clinical trial'?
It's a research study that tests new medical treatments or ways of using existing ones in people, to see if they are safe and effective.
Will I know which treatment I'm getting?
In some parts of the study, you might be randomly assigned to one treatment group or another. The study is 'open-label', meaning you and your doctor will know which treatment you are receiving.
What is the new drug 'tulmimetostat'?
Tulmimetostat is a new medicine being studied to see if it can help treat prostate cancer when combined with other drugs.
Can I stop participating if I want to?
Yes, you have the right to leave the study at any time, for any reason, and it will not affect your future medical care.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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