Extrait

Background and study aims Prostate cancer is a very common cancer affecting men. The prostate is a small gland in the pelvis. It is found only in men and is usually the size of a satsuma. Its function is to help with the production of semen, producing a thick white fluid to be mixed with sperm. Cancer of the prostate usually develops slowly, so patients may not be aware that they have the disease for many years. In some cases, the cancer is only diagnosed at a later stage, when the disease has already spread (and called metastatic prostate cancer). Symptoms include needing to urinate more frequently than before, needing to rush to the toilet, having problems passing urine, and feeling that the bladder is not completely empty after urinating. In advanced cases, the cancer may spread to the bones and lymph nodes and, more rarely, the lungs and the liver. Treatment options include radiotherapy, hormone therapy, chemotherapy and partial or complete removal of the prostate. Testosterone usually makes the cancer grow more quickly so treatments can be given to stop the body producing so much of this hormone. In some cases, the part of the testicle that produces the testosterone is removed. After a time, these treatments can stop working, at which point the cancer is known as castration resistant prostate cancer. Studies have shown that a treatment called abiraterone acetate (AA) can improve survival for men with metastatic castration-resistant prostate cancer. This study aims to gain a better understanding regarding the use of this drug in clinical practice. Who can participate? Men diagnosed with metastatic prostate cancer, treated with AA. What does the study involve? Patients are treated with 1000mg of AA once a day and 5mg prednisone twice a day. This treatment continues until the disease progresses, the participant dies or the treatment becomes too toxic to take any more. What are the possible benefits and risks of participating? Participants may benefit from taking part in this study though receiving a comprehensive, tailored follow-up. Where is the study run from? At least nine prostate cancer treatment centers in Italy. When is study starting and how long is it expected to run for? November 2015 to November 2016 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Luca Cindolo

Critère d'inclusion

• Metastatic Castration Resistant Prostate Cancer

Liens

• isrctn