A study looking at circulating tumour cells in men having treatment for advanced prostate cancer (CTC-STOP)

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if you are a man and all of the following apply.

• You have adenocarcinoma of the prostate that has spread to the bones after treatment with hormone therapy (castration resistant prostate cancer)
• You have at least 2 new areas of cancer spread in the bones, or your PSA level  is increasing. Your doctor will check for this  
• Doctors have tested your blood for circulating tumour cells (CTCs) and found at least 5 CTCs in 7.5 ml of blood. Your doctor can tell you about this
• You have had treatment with abiraterone or enzalutamide and you have stopped it because your cancer got worse (disease progression)  
• You are willing to have treatment with drugs that lower the amount of the hormone androgen such as degarelix, unless you have had surgery to remove both testicles (orchidectomy) 
• You have satisfactory blood tests results     
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
• You are at least 18 years old  
• You are willing to use reliable contraception during treatment and for a year afterwards if there is any possibility you can father a child 

Who can’t take part
You cannot join this study if any of these apply. 

Cancer related

• You have a rare type of prostate cancer called small cell prostate cancer
• Your cancer is pressing on the spinal cord (spinal cord compression ) and you need to have treatment with surgery or radiotherapy 
• Your cancer has spread to other parts of the body, apart from the bones
• Your cancer has spread to the brain or the membranes that surround the brain (carcinomatous meningitis) 
• You have had chemotherapy after stopping hormone therapy
• You have had hormone therapy in the past 28 days, apart from Zoladex or other similar drugs (luteinizing hormone blockers)
• You still have moderate or severe side effects from previous anti cancer treatment, apart from hair loss, low levels of red blood cells or any other side effect that doctors think was caused by anti androgen treatment
• You have had radiotherapy in the last 4 weeks (2 weeks if it was one radiotherapy treatment to help with symptoms)   
• You have had another cancer in the past 2 years apart from early bladder cancer or  basal or squamous cell skin cancer that have been successfully treated

Medical conditions

• You have had an experimental treatment as part of another clinical trial in the last 3 weeks 
• You take drugs that affect some enzymes called CYP3A. Your doctor can tell you about this 
• You have heart problems such as heart failure or you have had a heart attack in the last 12 months  
• You have had a stroke in the last 3 months
• You have had a blockage in a vein or artery that carries blood from the heart to the lungs in the last year (pulmonary thromboembolism) 
• You have had an infection that needed treatment in the last 3 months
• You are sensitive to docetaxel, cabazitaxel or anything they contain 
• You have any other serious medical condition that the trial team thinks could affect you taking part

Other

• You are having the yellow fever vaccine