clinical trial que começou a recrutar pacientes o ano passado. Vejam as condições, requisitos etc. Não sei se deve interessar a você, nem se sua participação é possível. Converse com seu oncólogo, particularmente se todos os recursos usuais tiverem sido esgotados. As regras são explícitas e estão transcritas abaixo.
A trial looking at abiraterone acetate and prednisolone for men with prostate cancer that has spread to another part of the body (COU-AA-301)
This trial is looking at an experimental drug called abiraterone acetate (CB7630) and the steroid prednisolone for men with prostate cancer that has spread to another part of the body and is no longer responding to hormone or chemotherapy treatment.
Doctors usually treat advanced prostate cancer with hormone therapy and chemotherapy. But if these treatments stop working, the cancer can be more difficult to control. So doctors are always looking for ways to treat this group of patients.
Doctors sometimes give the steroid prednisolone to treat advanced prostate cancer that has stopped responding to hormone therapy. Abiraterone acetate is a new type of therapy that works in a different way to other hormone treatments for prostate cancer. It blocks an enzyme called CYP17, which stops the body making the male hormone testosterone. Testosterone helps prostate cancer to grow. So doctors think that blocking the action of the CYP17 enzyme could help to slow the growth of prostate cancer or shrink it. But they are not sure yet.
The aims of the trial are to
Who can enter this trial
You can enter this trial if you
You cannot enter this trial if you
This is a phase 3 trial and will recruit 1,158 men worldwide. The men taking part are put into 2 different groups by computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial.
One group will have prednisolone and abiraterone acetate, the other group will have prednisolone and a dummy drug (placebo). About two thirds of the men will be put into the abiraterone acetate group and about one third of the men will be put into the placebo group. So, more men who take part in the trial will have abiraterone acetate than placebo.
You will take 4 tablets of either abiraterone acetate or the dummy drug, once, everyday. Everyone will also take a prednisolone tablet twice a day.
During treatment you will have some tests to see how well it is working. If the tests show treatment is helping, you will continue with the study treatment for as long as it is working and you don't have any serious side effects. If the tests show it is not helping, the trial doctor will decide to stop treatment. They will then discuss other options with you.
You will fill out a questionnaire before you start treatment and every 3 months during treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. You will fill out another questionnaire each month asking you specifically about pain and tiredness. These are called quality of life questionnaires.
Before you take part in this trial, a doctor will examine you and you will have some tests. Some of the tests include
When you start treatment, you will see the trial doctor at the hospital twice in the first month and then once a month after that. At each visit you will have a check up, some blood tests, and answer some questions about your current health. Every 3 months you will also have an ECG, a CT scan or MRI scan, and a bone scan. You will also have a MUGA scan repeated if you had mitoxantrone chemotherapy in the past.
Everyone will see the trial doctor 15 to 28 days after finishing treatment. They will repeat some of the tests you had before you started treatment. After the last trial visit, the trial doctor or nurse will contact you at home every 3 months to find out how you are feeling. You will continue to see your own doctor for routine appointments.
All treatments have side effects. Abiraterone acetate is an experimental drug and there may be some side effects that the doctors don't know about yet. In trials so far, the most common side effects were
Less common side effects included
You can read about the side effects of the steroid prednisolone on CancerHelp UK.
Parte superior do formulário
Location of trial
Parte inferior do formulário
The Information Nurses
Cancer Research UK
61, Lincoln's Inn Fields
Tel: 020 7061 8355
Email: [email protected]