A trial looking at a drug called MK-5684 for prostate cancer that has spread

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 advanced prostate cancer that is an adenocarcinoma type.
• Your cancer got worse while having treatment within the past 6 months. Or you have had an operation to remove both testicles and your cancer has got worse within the past 6 months. If you were having or had certain hormone treatment or chemotherapy treatment the timing is different. Your doctor can tell you more about this. 
• You have had a bone scan , CT scan  or an MRI scan  that shows your cancer has got worse. 
• You are taking medication that lowers or blocks the male sex hormone androgen. If you are taking a LH blocker and have not had surgery to remove the testicles, you must have started them at least 4 weeks before going into a treatment group (randomisation ) and continue taking them during the trial. Ask your doctor about this.
• If you are having medication to help your bones such as a bisphosphonate  or denosumab, you must have started it and be on a stable dose for at least 4 weeks before randomisation. 
• You have satisfactory blood test results. 
• You are willing to use reliable contraception during the trial and for a time after if there is any chance you could get someone pregnant. 
• You have a previous tissue sample (biopsy ) taken that the trial team can ask for and use. 
• You are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
• You are at least 18 years old. 

Who can’t take part

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

• have ongoing side effects from previous treatment. This is apart from mild side effects. Ask your doctor about this.
• have had certain medications for your cancer such as finasteride, oestrogen, cyproterone or any other cancer medication that reaches your whole body within 4 weeks of randomisation. This is including medication as part of another clinical trial. You can ask your doctor if this applies to you. 
• have had herbal preparations that lower the PSA level  within 4 weeks of randomisation
• have had more than 1 course of chemotherapy  that included a taxane drug  for the cancer that has spread and the cancer had got worse during treatment or after this treatment
• have active cancer that has spread to the brain, spinal cord or the thin tissue surrounding the brain. You can join if you have had treatment for this as long as it is stable for at least 4 weeks before joining and you have stopped taking steroids  for at least 2 weeks before starting the trial treatment.
• had a superscan bone scan. Your doctor will know about this. 
• had another cancer in the past 3 years that needed treatment or got worse. This is apart from successfully treated non melanoma skin cancer , a carcinoma in situ (CIS) , apart from CIS of the bladder.

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

• are not able to swallow tablets or capsules. Or you have a digestive system problem  that affects how well your body absorbs tablets or capsules.
• have or had a problem with the way the pituitary gland  works
• have diabetes that is not well controlled
• have high blood pressure that is not well controlled
• have had a heart attack within the past 6 months or any other significant heart problem
• have a myelodysplastic syndrome (MDS), or acute myeloid leukaemia (AML). Or your doctor thinks you might have signs and symptoms of them.
• have or had problems with how well your adrenal glands  work for example Addison’s disease
• have or had inflammation of the lungs (pneumonitis) and had steroids to treat it
• had major surgery and have not recovered within 28 days of randomisation
• are on hormone therapy for a thyroid gland  problem and the dose is not stable within 6 months of starting the trial treatment 
• had a whole blood transfusion within 120 days of randomisation. For packed red blood cells  and platelets  it is 28 days before randomisation. Your doctor will know this. 
• have radiotherapy within 2 weeks of starting the trial treatment or you have ongoing side effects from radiotherapy. For radiotherapy to control symptoms it is 1 week, unless it was for brain and spinal cord symptoms.
• have medication, including herbal preparations, that affect the CYP enzymes  within 2 weeks of starting the trial treatment 
• have an active autoimmune disease  that needed treatment in the past 2 years. This is apart from certain ones that your doctor will know about.
• have HIV unless it is well controlled with medication. You cannot join if you have or had Kaposi’s sarcoma or Multicentric Castleman’s Disease.
• have active hepatitis B and hepatitis C or any other active infection
• have any other medical condition, mental health condition or other circumstances that could affect you taking part

Other
You cannot join the trial if any of the following apply. You:

• want to start a family in the near future while you might be in the trial
• have a live vaccine  within 30 days of starting the trial treatment. The seasonal flu vaccine and the COVID-19 vaccine are not live vaccines.
• are allergic to any of the treatments, or any of their ingredients, used in this trial