Study of ORIC-944 in Patients With Metastatic Prostate Cancer
This study is testing a new medicine, ORIC-944, for men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer). The main goals are to check if ORIC-944 is safe to use and if it can help slow down or shrink the cancer. This new medicine will be tested both by itself and in combination with other common prostate cancer treatments like Abiraterone, Apalutamide, Darolutamide, and Enzalutamide. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. Researchers will also look for the best dose to give patients. It's hoped this could offer a new treatment option for those whose cancer has continued to grow.
Em resumo
Sobre o que é este estudo?
This research study is about a new drug called ORIC-944, which is being investigated as a potential treatment for men with prostate cancer that has spread to other parts of the body (this is called metastatic prostate cancer). Prostate cancer growth is often linked to male hormones, and many treatments aim to block these hormones. This new drug works in a different way, targeting a specific protein within cancer cells that plays a role in how they grow.
The main purpose of this study is to answer two key questions: First, is ORIC-944 safe for patients? This is really important when testing new medicines. Second, does ORIC-944 show any signs of helping to control or shrink the cancer? Researchers will explore this when ORIC-944 is given on its own, and also when it's given alongside other well-known prostate cancer medications like Abiraterone, Apalutamide, Darolutamide, and Enzalutamide. These are common treatments that work by blocking hormone signals.
Because this is an early-stage study, it will involve different steps. Initially, small groups of patients will be given increasing doses of ORIC-944 to find a dose that is well tolerated and potentially effective. Later stages will focus on finding the best dose to use with other existing treatments. The hope is that ORIC-944, either alone or in combination, could eventually provide another helpful option for men whose metastatic prostate cancer has continued to grow despite previous treatments.
Pontos principais
- This study investigates a new drug, ORIC-944, for advanced prostate cancer.
- It aims to establish the safety and initial effectiveness of ORIC-944.
- ORIC-944 will be tested alone and with other common prostate cancer medicines.
- The study is for men whose prostate cancer has spread and progressed on previous therapies.
- Participation involves regular check-ups, blood tests, and scans.
- It's an early-stage study, helping to find the best dose and understand side effects.
Quem pode ser elegível?
This study is looking for men aged 18 or older who have prostate cancer that has spread to other parts of their body. You must have already had surgery to remove your testicles (a bilateral orchiectomy), or you must be taking regular medication to keep your testosterone levels low.
Whether you can join also depends on what previous prostate cancer treatments you've had. If you're considering taking ORIC-944 on its own, you would generally need to have tried at least one 'next generation' hormone-blocking medicine (like abiraterone, apalutamide, darolutamide, or enzalutamide) and your cancer would have grown despite this. You also shouldn't have had too many chemotherapy treatments.
If you're considering taking ORIC-944 with another hormone-blocking medicine, you would usually have only had one previous line of that type of treatment. Your doctors will also need to see clear signs that your cancer is progressing, such as rising PSA levels or new signs of cancer growth on scans. You'll also need to be generally well enough to take part and have normal organ function.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Are you a man, 18 years or older?
- Do you have prostate cancer that has spread to other parts of your body?
- Have you had your testicles removed or are you taking medicine to keep your male hormone levels low?
- Has your prostate cancer continued to grow despite at least one previous hormone-blocking treatment (like Abiraterone, Apalutamide, Darolutamide, or Enzalutamide)?
- Are you generally well and able to perform your daily activities without much difficulty?
O que envolve a participação?
If you join this study, you'll be given the new medicine, ORIC-944, probably as a tablet, either on its own or alongside another prostate cancer treatment you might already be taking or have taken in the past. Because this is an early-stage study, you'll have regular hospital visits for check-ups. These visits will involve blood tests, scans, and possibly some small skin or tumour biopsies (where a tiny sample of tissue is taken) to see how the treatment is working and to monitor any side effects. You'll also be closely monitored to make sure your organs are functioning well.
The study will start by giving different groups of patients different doses of ORIC-944 to find the safest and most effective amount. The total length of your participation would depend on how your body responds to the treatment, but you would have regular follow-up appointments. The detailed plan of visits and tests will be explained fully by the study team, and you'll have ongoing support throughout.
Riscos e benefícios potenciais
Locations (27)
- Rocky Mountain Cancer CenterCódigo postal verificadoColorado Springs, Estados Unidos· Recrutamento
- South Florida Oncology and HematologyCódigo postal verificadoPlantation, United States· Recrutamento
- Illinois Cancer SpecialistsCódigo postal verificadoArlington Heights, United States· Recrutamento
- Comprehensive Urologic CareCódigo postal verificadoLake Barrington, United States· Recrutamento
- First UrologyCódigo postal verificadoJeffersonville, United States· Recrutamento
- Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of MarylandCódigo postal verificadoBaltimore, Estados Unidos· Recrutamento
- Maryland Oncology HematologyCódigo postal verificadoSilver Spring, United States· Recrutamento
- KarmanosCódigo postal verificadoDetroit, Estados Unidos· Recrutamento
- Minnesota Oncology HematologyCódigo postal verificadoMinneapolis, Estados Unidos· Recrutamento
- Memorial Sloane Kettering Cancer CenterCódigo postal verificadoNova Iorque, Estados Unidos· Recrutamento
- Instituto de Câncer LevineCódigo postal verificadoCharlotte, Estados Unidos· Recrutamento
- MidLantic UrologyCódigo postal verificadoBala-Cynwyd, United States· Ainda não recrutando
Perguntas frequentes
What is metastatic prostate cancer?
This is prostate cancer that has spread from the prostate gland to other parts of your body, such as the bones.
What does 'first-in-human' mean for this study?
It means this is one of the very first times this specific medicine, ORIC-944, is being given to people to check its safety and how it works.
What are ARPIs?
ARPIs stand for Androgen Receptor Pathway Inhibitors. These are medicines like Abiraterone, Apalutamide, Darolutamide, and Enzalutamide, which are commonly used to treat prostate cancer by blocking male hormones.
Will I get ORIC-944 alone or with another medicine?
The study is designed to test ORIC-944 both on its own and in combination with common ARPI medicines, depending on what part of the study you might be eligible for.
What happens if the medicine doesn't work for me?
If your cancer continues to grow or you experience significant side effects, the study doctors will discuss the next steps for your care, which may include stopping the study treatment.
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