A trial looking at docetaxel, zoledronic acid and strontium 89 for prostate cancer that has spread to the bones (Trapeze trial)

Please note this trial is no longer recruiting patients.

This trial is comparing different combinations of treatment including docetaxel, zoledronic acid (Zometa) and strontium 89 for prostate cancer that has spread to the bones.

Doctors usually treat prostate cancer with one or more of the following treatments - surgery, hormone therapy and radiotherapy. But sometimes these treatments don’t work, and the cancer continues to grow or even spread (metastasise) to another part of the body.

When cancer spreads to the bones it can be painful. Treatments to help slow the growth of the cancer and relieve the pain include chemotherapy (such as docetaxel), one of a group of drugs called bisphosphonates (such as zoledronic acid) or a type of radiotherapy called strontium 89.

In this trial they are comparing

Docetaxel (Taxotere) alone
Docetaxel with zoledronic acid (Zometa)
Docetaxel with strontium 89
Docetaxel with strontium 89 and zoledronic acid

These treatments are not usually given together. The aims of the trial are to find out more about how well the combinations work, and what the side effects are.

Recruitment

Start 01/02/2005

End 29/02/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have prostate cancer that has spread to your bones
Have had hormone therapy or an operation to remove your testicles (an orchidectomy), or both, and your PSA level is still rising
Are well enough for treatment (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old

You cannot enter this trial if you

Have had chemotherapy or strontium 89 for your prostate cancer in the past
Have taken bisphosphonate drugs in the last 2 months
Have had radiotherapy to more than a quarter of your bone marrow or to all of your pelvis
Have prostate cancer that has spread to your brain
Already have peripheral neuropathy unless it is very mild
Have had any other cancer in the last 5 years apart from basal cell skin cancer that was successfully treated
Are known to be sensitive to bisphosphonate drugs
Are taking part in any other clinical trial
Have had any experimental treatments in the last 30 days

Trial design

This is a randomised trial. It will recruit 1,240 patients into 4 groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will have docetaxel chemotherapy
Group 2 will have docetaxel and zoledronic acid
Group 3 will have docetaxel and strontium 89
Group 4 will have docetaxel, zoledronic acid and strontium 89

All groups have docetaxel through a drip into a vein once every 3 weeks. This takes about an hour each time. Each 3 week period is one treatment cycle. You will also take a steroid tablet called prednisolone every day while you are having chemotherapy.

If you are in group 1 or 3, you will have a maximum of 10 cycles of treatment.

If you are in group 2 or 4, you will have zoledronic acid through a drip into a vein once every 3 weeks for up to 10 cycles of treatment. Then once every 4 weeks after that for as long at the treatment helps you. This takes about 15 minutes each time.

If you are in group 3 or 4 you will have strontium 89 as an injection into a vein once only, 4 weeks after your 6th dose of docetaxel. There will then be a break of 4 weeks before you start the next cycle of treatment.

You will fill out a questionnaire before each cycle of treatment, then every month for 3 months and once every 3 months after that. It will ask you how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire.

The trial doctors will ask if they can take some extra blood samples when you visit hospital. They will study these samples to learn more about how prostate cancer responds to the treatments in this trial.

They will also ask your permission to look at samples of tissue taken when you were diagnosed with prostate cancer. If you don’t want to give these blood or tissue samples, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Physical examination
Blood tests (including a PSA test)
Urine tests
Chest X-ray
Bone scan
Bone density scan
CT scan, MRI scan or ultrasound scan

You will have blood and urine tests before each cycle of chemotherapy. You will go to the hospital once every 3 weeks for chemotherapy and zoledronic acid. You shouldn’t have to stay in hospital overnight.

If you are in group 3 or 4 and have strontium 89 after you finish chemotherapy, you will be able to go home later the same day.

After you finish treatment you will have some blood tests and see the doctors once a month for 3 months and then once every 3 months after that. You will have another CT or MRI scan, but exactly when will depend on other test results. You will have a bone density scan a year after you start treatment.

Side effects

The most common side effects of docetaxel are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Sickness
Fatigue
Rash or discoloured fingernails
Hair loss
Sore mouth
Diarrhoea
Numbness or tingling in hands and feet (peripheral neuropathy)
Muscle pain
Swelling because of fluid retention

The most common side effects of zoledronic acid are

Increased temperature and flu like symptoms
Bone pain
Reduced kidney function (this is temporary)

The most common side effects of strontium 89 are

Bone pain for 2 to 3 days afterwards
A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath

There is more information about docetaxel (Taxotere), zoledronic acid (Zometa) and strontium 89 on CancerHelp UK.