Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
This study, called DIRECT, is for men with prostate cancer that has spread to other parts of the body, but only a few spots. This is known as 'oligometastatic' cancer. We are investigating whether adding an extra tablet, enzalutamide, to the usual radiation and hormone treatment (called ADT) can improve how people feel and live their lives. In this study, some participants will receive the standard radiation and hormone therapy, while others will get the standard treatment plus enzalutamide tablets for about 8 to 9 months. Participants will be carefully monitored for up to 5 years. The aim is to find better ways to treat this type of prostate cancer and help men have a better quality of life.
At a glance
What is this study about?
This study is called DIRECT, which stands for "Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate". It's looking for better ways to treat prostate cancer that has spread to a few other places in the body. This is sometimes called 'oligometastatic' prostate cancer. Researchers want to see if combining standard treatments with a new medication makes a difference to how you feel and your quality of life.
At the moment, the usual care for this type of prostate cancer often involves hormone therapy (ADT) and radiation treatment. Hormone therapy works by blocking male hormones that can make prostate cancer grow. Radiation therapy targets and destroys cancer cells in specific areas. This study is testing if adding another tablet, called enzalutamide, to this standard treatment can further help control the cancer and improve life for patients.
Enzalutamide is a medication that also works by blocking male hormones, but in a different way to standard ADT. The study wants to understand if this additional treatment, given for a specific period (around 8-9 months), can lead to better outcomes compared to the standard treatment alone, particularly in terms of how it affects your daily life and well-being. By taking part, you could help doctors learn more about the best ways to treat this specific type of prostate cancer.
Key takeaways
- This study is for men with a limited number of prostate cancer spots that have spread.
- It compares standard treatment with standard treatment plus an additional tablet (enzalutamide).
- The main goal is to see if quality of life improves with the additional medication.
- Participation involves receiving assigned treatment and follow-up for up to 5 years.
- You will not have to take continuous hormone therapy if you join this study.
Who may be eligible?
To join this study, you need to be a man over 18 years old who has been diagnosed with prostate cancer that has spread to nearby areas (Stage IV) within the last six months. Importantly, your cancer should only have spread to a few spots (between 1 and 10). Some of these spots might only show up on a special type of scan called a PSMA PET scan, with only one spot visible on more common scans like CT or bone scans. All the areas where the cancer has spread must be treatable with radiation therapy.
It's also essential that you are generally well enough to take part, meaning you can carry out most of your daily activities without much difficulty. You must also be able to understand the study and agree to participate. A key point is that you should prefer not to have continuous hormone therapy as an ongoing treatment.
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.
- Are you over 18 years old?
- Have you been diagnosed with prostate cancer that has spread in the last 6 months?
- Has your cancer spread to 1 to 10 spots, all treatable with radiation?
- Are you generally well and able to carry out most daily activities?
- Do you prefer not to be on continuous hormone therapy?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of two groups by chance – like flipping a coin. One group will receive the standard treatment, which includes radiation therapy and hormone therapy (ADT). The other group will receive the standard radiation and hormone therapy, plus an extra tablet called enzalutamide for about 8 to 9 months.
Over the next five years, you'll have regular check-ups, either by visiting the clinic or through remote appointments (like phone calls or video calls). These check-ups are to see how you're responding to the treatment, monitor your health, and understand how the treatment affects your quality of life. This ongoing monitoring will help the study team learn whether the additional treatment makes a difference.
Potential risks and benefits
Locations (2)
- Princess Margaret Cancer CenterVerified postcodeToronto, Canada· Recruiting
- Sunnybrook Research InstituteVerified postcodeToronto, Canada· Active not recruiting
Common questions
What is 'oligometastatic' prostate cancer?
This means your prostate cancer has spread to a few, limited spots in your body, rather than many areas.
What is ADT?
ADT stands for Androgen Deprivation Therapy, which is hormone therapy to reduce male hormones that can fuel prostate cancer growth.
What is enzalutamide?
Enzalutamide is a tablet that blocks male hormones, working in a different way to standard hormone therapy, to help slow cancer growth.
How long will I be on the study medication if I get it?
If you are in the group receiving enzalutamide, you will take it for approximately 8 to 9 months.
Will I have to pay for the study treatments?
No, all treatments and assessments directly related to the study will be provided at no cost to you.
How to find out more
Rachel Glicksman, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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