This clinical trial is focused on studying a type of advanced prostate cancer known as Metastatic Castration-resistant Prostate Cancer (mCRPC). The study aims to compare a new medication called BMS-986365 with other treatments chosen by doctors, such as Docetaxel or medications that inhibit the androgen receptor pathway, like Abiraterone, Enzalutamide, Prednisolone, and Prednisone. These treatments are typically used to manage prostate cancer that has spread to other parts of the body.
The purpose of the study is to determine if BMS-986365 is more effective than the other treatments in delaying the progression of the disease. Participants will be randomly assigned to receive either BMS-986365 or one of the other treatments. The study will monitor how long it takes for the cancer to worsen, as well as overall survival, which refers to how long participants live while taking the medication. The study will use imaging techniques like X-rays or CT/MRI scans to track the progression of the disease.
Participants in the study will include men aged 18 or older who have this specific type of prostate cancer that is worsening. They should have evidence of cancer spreading, visible on scans, and should have previously tried certain treatments for prostate cancer. The study will continue until 2029, with the goal of providing valuable information on the effectiveness of BMS-986365 compared to other available treatments.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the new medicine called BMS-986365 or a treatment chosen by your doctor. This is to compare the effectiveness of the new medicine against existing treatments.
2treatment phase
If you are assigned to the BMS-986365 group, you will take this medicine orally in capsule form. The dosage and frequency will be determined by the study team.
If you are assigned to the doctor’s choice group, you may receive one of the following treatments: abiraterone, prednisolone, enzalutamide, prednisone, docetaxel, or another medicine. These medicines are also taken orally, except for docetaxel, which is given as an infusion (a slow injection into a vein). The specific dosage and frequency will be provided by your doctor.
3monitoring and assessments
Throughout the study, regular check-ups will be scheduled to monitor your health and the progress of your condition. This includes physical exams, blood tests, and imaging scans like X-rays or CT/MRI scans to see how the cancer is responding to the treatment.
You will also be asked to fill out questionnaires about your symptoms and overall well-being.
4end of treatment
The treatment phase will continue until your doctor determines that the treatment is no longer effective, or if you experience any side effects that require stopping the treatment.
At the end of the treatment, a final assessment will be conducted to evaluate your overall health and the outcome of the treatment.
5follow-up
After completing the treatment, follow-up visits may be scheduled to continue monitoring your health and to gather additional information about the long-term effects of the treatment.
Who Can Join the Study?
Men who are 18 years or older with a certain type of advanced prostate cancer that is getting worse.
Men who have signs of the cancer spreading to other parts of their body, which can be seen on special scans like a bone scan or a CT/MRI scan. These are imaging tests that help doctors see inside the body.
Participants will fill out questionnaires to ensure they are not suffering too much from their prostate cancer symptoms.
Participants should have also tried certain treatments before, like abiraterone, enzalutamide, apalutamide, or darolutamide, which are medicines used to treat prostate cancer.
Who Cannot Join the Study?
Patients who do not have Metastatic Castration-resistant Prostate Cancer (mCRPC) cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
Only male patients can participate in this study.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.
BMS-986365 is a new medicine being tested to see if it can help treat metastatic castration-resistant prostate cancer, a type of cancer that has spread and does not respond to treatments that lower testosterone. The goal of using BMS-986365 in this study is to find out if it can slow down the progression of the disease better than other treatments chosen by doctors.
Docetaxel is a type of chemotherapy used to treat various cancers, including prostate cancer. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the disease. In this study, Docetaxel is one of the treatment options that doctors might choose to compare against the new medicine, BMS-986365.
Second Androgen Receptor Pathway Inhibitor (ARPI) is a type of treatment that targets the androgen receptors in prostate cancer cells. These receptors help the cancer grow, and by blocking them, the treatment can slow down the cancer’s progression. In this study, a second ARPI is another treatment option that doctors might choose to compare against the new medicine, BMS-986365.
Metastatic Castration-resistant Prostate Cancer – This disease is a form of prostate cancer that continues to progress despite treatments that lower testosterone, which typically fuels prostate cancer growth. It is characterized by the spread of cancer cells beyond the prostate gland to other parts of the body, such as bones or lymph nodes. The cancer cells in this condition are resistant to hormonal therapy aimed at reducing male hormones. As the disease advances, patients may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. The progression of the disease is often monitored through imaging techniques to assess the spread and growth of cancerous cells. The condition is a significant challenge in prostate cancer management due to its resistance to conventional hormone therapies.
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