A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
This research study is for men with advanced prostate cancer. Its main goal is to find the best and safest doses of new drug combinations, specifically JNJ-87189401 and JNJ-78278343. In some parts of the study, these new drugs might be given with an existing prostate cancer medication called apalutamide, or with a treatment called Lutetium Lu-177 Vipivotide Tetraxetan (a type of targeted radiation therapy often used for prostate cancer). The study is in its early stages (Phase 1), meaning researchers are focusing on finding the right drug levels and understanding how safe these new combinations are, especially when tested with other treatments, for men with advanced prostate cancer.
At a glance
What is this study about?
This study is about exploring new ways to treat advanced prostate cancer. When cancer has spread from the prostate to other parts of the body, it's considered 'advanced'. Researchers are looking at two new drugs, called JNJ-87189401 and JNJ-78278343, to see how well they work together.
The main idea is to find out the safest and most effective dose for these combined drugs. This is an early-stage study, which means it's one of the first times these specific combinations are being tested in people. They want to understand how the drugs behave in the body and if they cause any side effects. Different groups of people in the study will receive different combinations – some might get just the two new drugs, others might get them along with an existing prostate cancer medicine called apalutamide, or with another treatment known as Lutetium Lu-177 Vipivotide Tetraxetan.
By carefully testing these combinations, the researchers hope to find treatments that are both safe and effective, potentially offering new options for men with advanced prostate cancer in the future. This kind of research is crucial for developing better medicines and improving care for people living with this condition.
Key takeaways
- This study is testing new drug combinations for advanced prostate cancer.
- It's an early-stage study focused on finding safe doses and understanding side effects.
- The new drugs might be combined with existing prostate cancer treatments.
- You'll have regular hospital visits for check-ups and tests if you take part.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, doctors will first check if you have prostate cancer that has been confirmed by a biopsy. It can be a specific type called adenocarcinoma, including those with small cell or neuroendocrine features, but not other types of small cell or neuroendocrine cancers. Your cancer also needs to be measurable, meaning doctors can track its size.
You should have already had a procedure to remove your testicles (an orchiectomy) or be receiving ongoing hormone therapy shots for at least two weeks before starting the study drugs. This hormone therapy must continue throughout your time in the study. You also need to be generally well and able to carry out most daily activities without too much difficulty.
There are some reasons why you might not be able to join. For example, if you've had an autoimmune disease in the past year, or a heart attack, serious angina, heart failure, or a stroke-like event within the last six months. These conditions could make the study treatments unsafe for you. The study is open to men aged 18 and older.
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.
- Do I have advanced prostate cancer that has been confirmed by a doctor?
- Have I had an orchiectomy or am I currently on hormone therapy for prostate cancer?
- Am I generally well and able to manage most daily activities?
- Have I had any serious heart problems or an autoimmune disease in the past year?
- Am I aged 18 or older?
What does participation involve?
If you decide to take part in this study, you'll receive the new study drugs or drug combinations as prescribed by the research team. You will have regular appointments at the study clinic, where doctors and nurses will monitor your health closely. This will involve physical examinations, blood tests, urine tests, and scans (like CT scans or bone scans) to see how the treatment is working and check for any side effects. The exact number of visits and tests will depend on which part of the study you are in.
Some parts of the study might involve taking the new drugs alongside other common prostate cancer treatments you might already be on, such as apalutamide or Lutetium Lu-177 Vipivotide Tetraxetan. All your medication dosages will be carefully managed by the study team. You'll continue with these treatments and regular check-ups for a set period, and then there will be a follow-up period to monitor your long-term health. The total duration of your participation, including follow-up, will be explained in detail.
Potential risks and benefits
Locations (15)
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States· Recruiting
- Emory University Winship Cancer InstituteVerified postcodeAtlanta, United States· Recruiting
- University Of MinnesotaVerified postcodeMinneapolis, United States· Recruiting
- START New JerseyVerified postcodeEast Brunswick, United States· Recruiting
- Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterVerified postcodeNew York, United States· Recruiting
- Oregon Health And Science UniversityVerified postcodePortland, United States· Recruiting
- Sidney Kimmel Cancer Center - Jefferson HealthVerified postcodePhiladelphia, United States· Recruiting
- Tennessee OncologyVerified postcodeNashville, United States· Recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- South Texas Accelerated Research Therapeutics, LLC (START)Verified postcodeSan Antonio, United States· Recruiting
- Swedish Medical CenterVerified postcodeSeattle, United States· Recruiting
- Institut BergonieVerified postcodeBordeaux, France· Recruiting
Common questions
What is 'advanced prostate cancer'?
It means the prostate cancer has spread from where it started to other parts of your body. Doctors sometimes call this 'metastatic' cancer.
What does 'Phase 1' study mean?
Phase 1 is the earliest stage of human testing. Researchers are mainly focused on finding the safest dose of the new drugs and understanding how the body reacts to them.
What are JNJ-87189401 and JNJ-78278343?
These are the special research names for new drugs being tested in this study. They don't have common names yet.
Will I definitely receive the new drugs?
If you're eligible, you will receive the study drugs. This trial isn't comparing them to a dummy treatment (placebo); it's testing different combinations and doses of the new drugs, sometimes with existing treatments.
What if I feel unwell during the study?
You will have regular contact with the study team. You should always tell them about any new symptoms or how you are feeling, so they can provide the best care and adjust your treatment if needed.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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