Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial
This study, called REINFORCE, is for men with prostate cancer that has spread to other parts of the body and is still sensitive to hormone treatment. It's for those who have started on a medication called apalutamide (Erleada), but their cancer hasn't responded as much as doctors hoped. The study is investigating whether adding another chemotherapy drug, docetaxel, to apalutamide can be more effective. The main goal is to see if this combination can stop the cancer from getting worse for a longer time. Researchers will also look at how this treatment affects quality of life and other important aspects of health.
At a glance
What is this study about?
This study is called REINFORCE and it's looking into a new way to treat prostate cancer that has spread to other parts of the body. This particular type of prostate cancer is still sensitive to hormone treatment, which means it often responds well to medicines that reduce male hormones. The study is focused on men who have started treatment with a drug called apalutamide (often known as Erleada), but their doctors feel the cancer hasn't shrunk or been controlled as much as they'd hoped.
The study wants to find out if adding another chemotherapy drug, docetaxel, to the existing apalutamide treatment can make a bigger difference. Doctors call this 'treatment intensification'. The main aim is to see if this combination can keep the cancer from growing or spreading further for a longer period. This is really important for improving how long people can live well with the condition.
Researchers will also be carefully checking many other things. This includes seeing how the treatment affects the time until the cancer becomes resistant to hormone therapy, if it slows down cancer spread seen on scans, and how it impacts overall survival. They will also pay close attention to side effects and how the treatment affects your daily life and pain levels to ensure any benefits outweigh potential issues.
Key takeaways
- This study aims to find a better way to treat prostate cancer that has spread.
- It combines existing medications: apalutamide tablets and docetaxel chemotherapy.
- It's for men whose cancer didn't respond enough to initial apalutamide treatment.
- The main goal is to see if the combination stops cancer from worsening for longer.
- Your well-being and quality of life are important parts of the research.
- Participation involves regular check-ups, tests, and questionnaires.
Who may be eligible?
This study is specifically for men who are at least 18 years old and have prostate cancer that has spread to other parts of the body. Your cancer must still be sensitive to hormone treatment, meaning it responds to medicines that lower male hormones.
You would be considered for this study if you have already started treatment with a specific drug called apalutamide (Erleada), but your doctors believe your cancer hasn't responded as strongly as expected. This usually means your PSA (Prostate-Specific Antigen) levels haven't dropped enough after initial treatment.
There will also be other health checks and criteria that your study doctor will discuss with you to make sure the study is a safe and suitable option for your unique health situation.
- Are you a man aged 18 or older?
- Do you have prostate cancer that has spread to other parts of your body?
- Has your cancer been found to be 'hormone-sensitive'?
- Are you currently being treated with apalutamide (Erleada)?
- Has your doctor indicated that your PSA levels haven't dropped enough on your current treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive either the standard apalutamide treatment or the combination of apalutamide plus docetaxel, depending on which group you're randomly assigned to. You would take apalutamide tablets daily. Docetaxel is given intravenously, meaning through a drip into your arm, usually on a regular schedule.
Throughout the study, you would have regular appointments with the study team. These appointments would involve physical exams, blood tests (including PSA levels), and scans to monitor your cancer. You would also be asked to complete questionnaires about your quality of life, pain, and how you are feeling. The exact number and frequency of visits and tests would be clearly explained by the study team. Treatment will continue as long as it's helping and you are tolerating it well. After active treatment, there would be a follow-up period to continue monitoring your health, which could last several years.
Potential risks and benefits
Locations (4)
- —Spain
- —Germany
- —France
- —Portugal
Common questions
What is 'hormone-sensitive prostate cancer'?
This means your prostate cancer still responds to treatments that lower male hormones in your body, which helps to slow its growth.
What is PSA?
PSA stands for Prostate-Specific Antigen. It's a protein made by prostate cells, and its level in the blood can be used to monitor prostate cancer.
What does 'treatment intensification' mean?
It means adding another treatment to your current medication with the goal of making the overall treatment stronger and more effective.
Will I know which treatment I'm getting?
Yes, in this study, it's 'open-label', meaning both you and your doctor will know whether you are receiving apalutamide alone or with docetaxel.
Can I stop the study treatment if I want to?
Yes, you have the right to leave the study at any time, for any reason, and your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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