(20510) A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of androgen receptor pathway inhibitor (ARPI) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of ARPI
This clinical trial is for men with advanced prostate cancer that has spread mostly to the bones and is no longer responding to standard hormone therapy. Researchers are comparing two existing treatments to see which works better. One group will receive radium-223, an injection that targets cancer in the bones. The other group will take standard hormone-blocking tablets, such as abiraterone with a steroid or enzalutamide. Both treatments are already approved for use, but doctors want to directly compare them after a previous hormone therapy has stopped working. The study aims to find out which treatment helps men live longer and delays bone pain or fractures. Taking part involves regular hospital visits, scans, blood tests, and questionnaires to track your symptoms, bone health, and overall quality of life.
Em resumo
Sobre o que é este estudo?
Prostate cancer is one of the most common cancers in men. Sometimes, the cancer can spread to other parts of the body, most commonly the bones. When it reaches the bones, it can cause pain, weaken the skeleton, and increase the risk of fractures. In many cases, the cancer continues to grow even when standard testosterone-lowering treatments are used. When this happens, doctors need effective next-step options to keep the cancer under control.
This study compares two different standard treatments for men whose cancer has spread mainly to the bones and has worsened after taking a hormone-blocking drug. One treatment is radium-223, an injection that goes straight to areas of bone damage to target cancer cells. The other treatment involves switching to an alternative hormone-blocking tablet, such as abiraterone (taken with a mild steroid) or enzalutamide. Both approaches are already used in routine care, but doctors want clearer evidence on which one is more effective at this stage of the illness.
The main goal of the trial is to see which option helps men live longer. Researchers also want to find out which treatment is better at delaying bone complications, such as severe pain or broken bones, and how each option affects day-to-day quality of life. The results could help doctors choose the best path forward for men facing advanced prostate cancer in the future.
Pontos principais
- The trial compares radium-223 injections with standard hormone tablets for advanced prostate cancer.
- It is for men whose cancer has spread mainly to the bones and has progressed after a previous hormone therapy.
- The main aim is to discover which treatment helps patients live longer and reduces bone complications.
- You will be randomly assigned to one of the two standard treatment approaches.
- Taking part involves regular clinic visits, blood tests, scans, and pain assessments.
- Participation is entirely voluntary and you can stop at any time.
Quem pode ser elegível?
This study is open to adult men aged 18 and over who have advanced prostate cancer. To be eligible, the cancer must have spread primarily to your bones rather than to major organs like the liver or lungs. It must also be 'castration-resistant', meaning the cancer is still growing even though testosterone levels are kept very low by treatment.
You may be suitable if you have already taken one line of modern hormone-blocking tablets (such as abiraterone or enzalutamide) and tests now show that the cancer is progressing again. Your doctor will review your general fitness, blood test results, and recent scans to make sure it is safe for you to take part.
Men whose cancer has spread significantly to organs other than the bones, or who have certain other serious health problems, may not be able to join. The study team will carry out detailed checks to confirm whether the trial is a safe and appropriate choice for you.
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.
- I am a man aged 18 or older.
- I have been diagnosed with advanced (metastatic) prostate cancer.
- My cancer has spread mostly to my bones.
- My cancer is growing despite treatments that lower testosterone.
- I have already tried one type of modern hormone tablet (such as abiraterone or enzalutamide).
- I am well enough to attend regular hospital appointments.
O que envolve a participação?
If you take part, you will be randomly placed by a computer into one of two treatment groups. One group will receive injections of radium-223 into a vein once every four weeks for up to six doses. The other group will take daily hormone-blocking tablets at home. You will attend the clinic regularly for health checks, which include blood tests, physical examinations, and scans (such as bone scans and CT scans) to monitor your cancer.
During your visits, the research team will ask you to fill in short questionnaires about any bone pain you feel and how you are managing daily activities. You will also be asked about any side effects you experience. Your participation will last for as long as the treatment is helping you, followed by regular check-ups to track your long-term health and wellbeing.
Riscos e benefícios potenciais
Locations (10)
- —Não verificadoItália
- —Não verificadoPolônia
- —Não verificadoLituânia
- —Não verificadoÁustria
- —Não verificadoHungria
- —Não verificadoFrança
- —Não verificadoFinlândia
- —Não verificadoAlemanha
- —Não verificadoChéquia
- —Não verificadoEspanha
Perguntas frequentes
What is radium-223 and how does it work?
Radium-223 is a liquid medicine given through a vein. It acts like calcium, travelling directly to parts of the bone where cancer is active to deliver targeted treatment while sparing most healthy tissue.
Can I choose which treatment I receive?
No. A computer randomly assigns you to either the radium-223 group or the hormone tablet group. This ensures the trial results are fair and scientifically accurate.
Will taking part cost me anything?
No. The trial medication and all study-related tests are provided free of charge. Some hospital sites may also help cover travel expenses.
What happens if my cancer worsens during the study?
Your safety is the priority. If scans or tests show your cancer is growing or the treatment is no longer working, the trial treatment will stop and your doctor will discuss other standard care options with you.
Can I leave the trial if I change my mind?
Yes. You have the right to leave the study at any point. Your decision will not change your relationship with your medical team or the quality of your care.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
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Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.