For trial participants

The Trapeze study is an academic clinical trial for patients who have Prostate Cancer which has spread to include the bone (Metastatic Prostate Cancer).

For information on Prostate Cancer and other cancer types please visit Cancer Research UK.

Aims

It is believed that chemotherapy may be beneficial in treating your prostate cancer. Chemotherapy is currently a standard treatment for prostate cancer that has spread to the bone. The main aim of this study is test the effects of combining two further known treatments for prostate cancer at different time points, with chemotherapy.

The aim of the study is to assess how effective and safe Zoledronic acid (Zometa) or Strontium-89 is in treating your disease when given in combination with chemotherapy.

Side Effects

As with all medicines of this type there may be some unwanted side effects. You should discuss these with your doctor. The more common side-effects are listed below; there may also be other side effects that we cannot predict. Other medicines will be given to make side effects less serious and less uncomfortable.

Docetaxel (Taxotere®)

With Docetaxel (Taxotere®) you may experience nausea and/or vomiting, mouth irritation, diarrhoea, fatigue, a pins and needles sensation * in your hands or feet, hair loss, changes in your skin and nails, muscular pain, decrease in blood cell counts, infection, and swelling due to fluid retention. Your blood pressure may also fall while the drug is being given, and this will be checked carefully. The infusion of Docetaxel (Taxotere®) may cause temporary local irritation and bruises if it is given into a small vein. All these side-effects have been experienced by some patients during previous studies and most of them are reversible. * (The items underlined may not be reversible).

Docetaxel (Taxotere®) + Zoledronic acid (Zometa®)

With Docetaxel (Taxotere®) + Zoledronic acid (Zometa®) you may experience the same effects as stated for Docetaxel (Taxotere) above with a rise in temperature, and flu-like symptoms, consisting of fever and bone pain due to the Zoledronic acid (Zometa). Zoledronic acid may also affect your kidney function. Blood samples will be taken prior to zoledronic acid (Zometa) infusion at every study visit to check that your kidney function has not been affected.

Docetaxel (Taxotere®) + Zoledronic Acid (Zometa®) + strontium-89

With Docetaxel (Taxotere®) + Zoledronic Acid (Zometa®) + strontium-89 you may experience the same side effects as stated above for Docetaxel (Taxotere®) and Zoledronic acid (Zometa). The addition of Strontium-89 to Docetaxel (Taxotere) and Zoledronic acid (Zometa®) may cause some bone pain lasting 36 to 72 hours following injection. This can usually be controlled by analgesics (pain killers). Strontium-89 can also affect your blood counts following injection; these will be monitored very closely with regular blood tests.

Docetaxel (Taxotere®) + strontium-89

With Docetaxel (Taxotere®) + strontium-89 the addition of Strontium-89 to Docetaxel (Taxotere) may cause some bone pain lasting 36 to 72 hours following injection. This can usually be controlled by analgesics (pain killers). Strontium-89 can also affect your blood counts following injection; these will be monitored very closely with regular blood tests.

Chemotherapy

As with any chemotherapy it is possible that your treatment could cause problems to an unborn child. You must take full contraceptive precautions if there is any chance of you fathering a child during and for at least 2 months after the treatment.

If you have a fever or bruising after receiving either of the drug combinations, it is important that you contact your hospital doctor immediately. If you have a fever your doctor will perform some blood tests and may prescribe antibiotics.

For more information about risks and side effects, ask your doctor.You may require one extra bone scan more than you would if you were not taking part in the study. You may require one additional CT scan and will receive two additional bone density scans.

(DXA scans) more than you would receive if you were not taking part in the study. Any potential health risk associated with these or any of the above scans is considered to be low for a patient with your medical condition. The radioactive strontium is intended to give a very high radiation dose to any parts of your bones that are involved in your cancer.

The rest of your body gets a lower radiation dose and your doctor will explain possible side effects with you. Any potential health risk associated with the radiation is considered to be minimal for a patient with your medical condition.

If you have private medical insurance you may wish to to consult your medical insurers before agreeing to take part in the study. This is to ensure that you participation will not affect your medical insurance cover.

Hospital visits

A patient enrolled onto this study will be expected to visit the hospital every 3 weeks for chemotherapy treatment for 15 weeks.

After this period patients will be expected to attend the hospital on a regular basis for a maximum follow up period of 2 years.

Treatments and potential benefits

When we do not know which way of treating patients is best, we need to make comparisons. Everyone who agrees to take part in this study will be put into a treatment group.

Approximately 300 patients with cancer no longer responding to hormone treatment will be asked to take part in this study. The study will be open to recruitment for up to 2 years.

The three treatments involved in this study are described below.

Docetaxel (Taxotere®)

A chemotherapy drug and is approved in the UK for the treatment of advanced breast and lung cancer. Docetaxel (Taxotere®) has been approved for use within clinical trials for the treatment of prostate cancer. Recently published studies (including an international prostate cancer clinical trial study called Tax-327) demonstrate that Docetaxel (Taxotere) improves symptom control and survival times.

Zoledronic acid (Zometa®)

A bone-strengthening agent approved in the UK for treating cancer affecting the bone.

Strontium-89

A type of radiotherapy (given by an injection), which is also approved in the UK for treating cancer affecting the bone. Early studies show that it may provide additional pain relief when combined with chemotherapy and may improve your condition.

Chart showing TRAPEZE treatments

Randomisation

The treatment you receive will be chosen by a process called randomisation, the treatment is randomly allocated by computer, which is like making a choice by tossing a coin. This means that you have an equal chance of being treated with one of the above treatments. You and your doctor will know which treatment you are receiving.

The Four treatment groups in this study are:

A) Docetaxel (Taxotere®)

B) Docetaxel (Taxotere®) + Zoledronic acid (Zometa®)

C) Docetaxel (Taxotere®) + Strontium-89

D) Docetaxel (Taxotere®) + Zoledronic acid (Zometa®) + Strontium-89

Potential Benefits

The use of chemotherapy may result in a decrease in pain, improvement in the quality of life and a delay in the progression of your disease and improved survival times. This may be further improved by combining chemotherapy with Zoledronic acid (Zometa®) and/ or Strontium-89.

The information we get from this trial may help us to treat other patients with cancer more effectively in future.

Trapeze logo with a large red letter T and the abbreviation below.