Experimento (clinical Trial phase III) com abiraterona

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

• Find out how well abiraterone acetate, or placebo (dummy drug), and prednisolone works for advanced prostate cancer
  
• Learn more about the side effects and quality of life
  

Who can enter this trial

You can enter this trial if you

• Have prostate cancer that has spread (metastasised) to another part of the body apart from the brain
  
• Have had hormone therapy in the past but it stopped working
  
• Have had at least one, but no more than two chemotherapy regimes in the past for prostate cancer, and it continued to grow despite this - one of the treatments must have included a drug called docetaxel
  
• Have had hormone therapy or surgery (bilateral orchidectomy) that caused your testosterone level to fall below 50ng/dl (your doctor can advise you on this)
  
• Are able to take medication by mouth
  
• Have satisfactory blood test results
  
• Are well enough for treatment (performance status 0, 1 or 2)
  
• Are willing to use reliable contraception if there is any chance that your partner could become pregnant
  

You cannot enter this trial if you

• Have prostate cancer that has spread to your brain
  
• Have had a drug called ketaconazole in the past
  
• Have had abiraterone acetate before or any medication that blocks the action of the CYP17 enzyme - you can check this with your doctor
  
• Have high blood pressure that isn't well controlled with medication
  
• Have hepatitis or long term liver disease
  
• Have a serious heart problem
  
• Have had problems with your pituitary gland or adrenal glands in the past
  
• Have a disorder that affects how your gut absorbs food or medicines
  
• Have had any other cancer in the past and a high chance of it coming back
  
• Have any other medical condition or there is any other reason why you won't be eligible to take part in this trial - your trial doctor will advise you on this
  

Trial design

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.

Hospital visits

Before you take part in this trial, a doctor will examine you and you will have some tests. Some of the tests include

• Blood tests
  
• Urine tests
  
• Chest X-ray
  
• ECG (heart trace)
  
• CT scan or MRI scan of your chest, stomach and lower abdomen (pelvic area)
  
• Bone scan
  
• MUGA scan or echocardiogram
  

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.

Side effects

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

• Tiredness
  
• A rise in blood pressure
  
• A low level of potassium in the blood
  

Less common side effects included

• Headache
  
• Water retention causing shortness of breath and swollen legs
  
• Constipation or diarrhoea
  
• Feeling or being sick
  
• Decreased appetite
  
• Hot flushes
  
• Tummy pain
  
• Cough
  
• Dry mouth
  
• Abnormal liver function test results
  

You can read about the side effects of the steroid prednisolone on CancerHelp UK.

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Location of trial

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Contact details

The Information Nurses
Cancer Research UK
P.O.Box 123
61, Lincoln's Inn Fields
London
WC2A 3PX
Tel: 020 7061 8355
Email: [email protected]