A trial looking at AZD5305 and darolutamide before surgery for prostate cancer (ASCERTAIN)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have prostate cancer that has recently been diagnosed
• have prostate cancer that has a higher risk of coming back after treatment. Your doctor will know this. 
• are suitable to have surgery to remove the prostate 
• can switch to a medication called heparin if you are taking a medication called warfarin to thin your blood. Your doctor will know this. 
• have a sample of tissue available (biopsy )  that the trial team can access or you are willing to give a new sample 
• have satisfactory blood test results 
• are at least 18 years old 

As well as the above, the following must also apply if you are having AZD5305, darolutamide or both. You: 

• are willing to use reliable contraception during the trial and for a period after if there is any chance your partner could become pregnant 
• are willing not to donate sperm during the trial and for a period after 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have already had treatment for localised prostate cancer 
• have myelodysplastic syndromes or acute myeloid leukaemia or your doctor suspects you have this 
• have had another cancer in the last 3 years that could affect you taking part in the trial. Or you have had treatment for another cancer in the last 3 years. You can take part if you had surgery for a local cancer and this treatment was successful. 
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 3 weeks of starting trial treatment. 

Medical conditions
You cannot join this trial if any of these apply. You:

• have had a heart attack in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• are taking medication that can affect your heartbeat
• have high blood pressure that isn’t controlled with medication or low blood pressure that is causing symptoms 
• have had a stroke in the last 6 months 
• are feeling or being sick and this isn’t well controlled with medication, you have a long term problem with your gut or you can’t swallow or absorb medication 
• have had treatment that stimulates or damps down the immune system within 4 weeks of starting trial treatment. You can take part if you are having low dose steroid treatment .
• have an active bleeding problem or are at risk of having a bleed. Your doctor will know this. 
• have HIV, an active hepatitis B or hepatitis C infection or any other infection that needs treatment 
• are taking medication that affects substances in the body called CYP enzymes. This doesn’t apply if you are in the surgery group. 

Other 
You cannot join this trial if any of these apply. You:

• can’t have darolutamide or AZD5305 for any reason 
• are allergic to AZD5305 and darolutamide or anything they contain
• would like to have children in the future