Efficacy and safety of cannabidiol for pain relief of patients with end-stage metastatic castration resistant prostate cancer - a randomised double-blinded placebo-controlled phase II trial (ProCan)
This research study, called ProCan, is investigating a new way to help men who have prostate cancer that has spread and is difficult to treat. We're looking at a cannabis-based medicine called cannabidiol (CBD) to see if it can help relieve pain. Some people will get CBD, and others will get an inactive dummy treatment (placebo) – neither you nor your doctor will know which you are receiving until the end of the study. The main aim is to see if CBD helps reduce the amount of strong pain relievers (like morphine) people need. We will also check how it affects pain levels, daily activities, quality of life, and any side effects. This is a Phase II study, meaning we are exploring if it works and is safe before moving to larger studies.
At a glance
What is this study about?
This study is called ProCan, and it's for men who have prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments. We know that pain can be a big problem for people with advanced cancer, and doctors often prescribe strong painkillers, called opioids, to help.
We want to find out if cannabidiol (CBD), which comes from the cannabis plant, could be another way to help manage this pain. CBD is different from recreational cannabis; it doesn't cause a 'high.' In this study, we're comparing CBD with a 'placebo,' which looks exactly like the CBD but contains no active medicine. This helps us understand if any improvements are truly due to the CBD or just from other factors. By doing this comparison, we can see if CBD might help reduce the amount of strong painkillers people need, improve their pain, and potentially make their daily lives better.
This is a 'Phase II' study, which means it's an important early step. We're exploring if CBD is safe and if it seems effective for pain relief in this group of patients. If the results are promising, it could lead to larger studies and potentially new ways to help manage cancer pain in the future. We are committed to finding better ways to support patients living with advanced prostate cancer.
Key takeaways
- This study explores CBD for pain in advanced prostate cancer.
- It aims to see if CBD can reduce the need for strong painkillers.
- Participants will receive either CBD or a dummy treatment.
- The study also looks at pain levels, quality of life, and safety.
- It's a Phase II study, an early step in researching new treatments.
Who may be eligible?
This study is specifically looking for men who are at least 18 years old.
You would need to have prostate cancer that has spread to other parts of your body. Your cancer should also be a type that doctors call 'castration-resistant,' meaning standard hormone treatments are no longer fully working to control it.
There might be other health conditions or medications that mean you can't join the study, so your doctor will need to check everything carefully to make sure it's safe for you.
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 male?
- Are you 18 years old or older?
- Do you have prostate cancer that has spread?
- Is your prostate cancer 'castration-resistant' (meaning hormone treatments are less effective)?
- Are you willing to discuss all your current medications with the study team?
What does participation involve?
If you decide to take part, you will be given either cannabidiol (CBD) or a dummy treatment (placebo) to take. Neither you nor your study doctor will know which one you are receiving until after the study ends. You'll have regular visits to the clinic, where the study team will monitor your pain levels, how much pain medication you are using, and ask about your general well-being and quality of life.
You'll also be asked to keep a record of your pain and any medicines you take. The team will want to know if taking the study medicine affects your daily activities and how much you can move around. They will carefully check for any side effects you might experience. Throughout the study, you'll have support from the research team, who will be there to answer your questions and monitor your health closely.
Potential risks and benefits
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Common questions
What is cannabidiol (CBD)?
CBD is a substance found in the cannabis plant. Unlike THC, which is another part of cannabis, CBD does not make you feel 'high' and isn't typically used for recreational purposes.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers understand if the medicine itself is causing any effects, or if the effects are from other factors.
Will I know if I'm getting CBD or a placebo?
No, neither you nor your study doctor will know whether you are receiving CBD or the placebo. This is called 'double-blinded' and helps make the study results more reliable.
What is 'Phase II' of a clinical trial?
Phase II is an early stage where doctors are exploring if a new treatment is safe and seems to work for a specific condition. If it looks promising, it moves on to larger studies.
Can I stop participating in the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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