Trial to find the best treatment for prostate cancer

Cancer Research UK

A NEW Cancer Research UK clinical trial has been launched to investigate the best treatment options for men who have had surgery for early stage prostate cancer.

The trial - named RADICALS* - is partly funded by the Medical Research Council (MRC) and Cancer Research UK and aims to provide the definitive guide on when and how to use radiotherapy and hormone therapy to treat prostate cancer after surgery.

Prostate cancer is the most common cancer in men in the UK. Over the last 30 years prostate cancer rates have tripled, largely due to the increasing use of PSA testing, which has led to more diagnoses.

Early stage prostate cancer - cancer contained within the prostate gland - is often treated with surgery. Some patients, depending on their PSA** test results after surgery will then be given either radiotherapy, or a combination of radiotherapy and hormone therapy.

The use of these treatments varies across the country and doctors are uncertain about which treatment is best for all men.

Dr Chris Parker, from the Institute of Cancer Research, is chief investigator for the trial and said: "There's a lot of uncertainty around how to treat men who have had their prostate removed. PSA testing is likely to increase in the future. This will result in more men being diagnosed with prostate cancer. So this investigation is essential to ensure that all men receive the best treatment."

Researchers want to understand, firstly whether further treatments should be given to all men and for how long, regardless of their PSA levels. And secondly, when radiotherapy should be given and whether it is more effective to use it alone, or to combine it with hormone therapy.

Jim Stansfeld, who represents the patients on the RADICALS trial, said: "Back in 1998 and after surgery to remove my prostate gland, I was identified as having an aggressive cancer and it was possible that not all of it had been removed. Clearly some follow up treatment was necessary but what would be best?

"The RADICALS trial sets out to help answer this question so that in the future patients can be well advised. I feel strongly that those who are able to join this trial should do so, for their own benefit, and also to add to this knowledge that will benefit men in the future."

This international study will recruit over 4,000 men. Patients who are about to have a prostatectomy - removal of the prostate gland - or who have had surgery in the past and are about to have radiotherapy, are likely to approached by their specialist to see if they would like to participate in the trial.

Kate Law, Cancer Research UK's director of clinical trials, said: "Prostate cancer is now the most common cancer in men in the UK - there are around 35,000 men newly diagnosed with prostate cancer every year, that's more than 650 new cases every week. It's vital that we continue research like this to understand more about the best way to treat this disease for all men."

For more information about this or any other cancer clinical trial please visit the CancerHelp UK website, or call our specialist nurses on 020 7061 8355.

ENDS

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Notes to Editor

* RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

**PSA - Prostate Specific Antigen - this is a chemical produced by prostate gland cells and is contained in seminal fluid.

Some PSA seeps out of the prostate and into the blood stream, and it is here that doctors can test for levels. When the prostate gland enlarges the PSA levels increase because there are more cells to secrete PSA. Therefore increased PSA levels can be a sign of prostate cancer. But the prostate grows as men get older and 'normal' PSA levels vary from man to man.

The PSA level can also increase for other reasons, such as infection, so this alone is not a reliable test for cancer. Two out of every three men with raised PSA levels don’t have prostate cancer. Doctors combine a PSA test with a rectal examination in order to diagnose prostate cancer, but a definite diagnosis can only be obtained by taking a tissue sample.

Anyone affected by cancer can contact Cancer Research UK's cancer information nurses on 0808 800 4040 (freephone) or visit the charity's patient information website www.cancerhelp.org.uk.

RADICALS Trial Design

At the start of the trial all men will be assessed and those who definitely need radiotherapy - about one in ten - will receive it. Those men who definitely don’t need radiotherapy - about five in ten - will be monitored, and if their PSA levels rise can join the trial and receive radiotherapy. For the remaining men - four in ten - it is uncertain whether they need radiotherapy or not. They will be randomly divided into two groups. One group will receive regular monitoring and the other group will receive radiotherapy.

All those men receiving radiotherapy will be randomly divided into three groups. The first group will receive radiotherapy alone. The second group will have radiotherapy with hormone therapy for six months, and the final group will have radiotherapy with hormone therapy for twenty-four months.

Matthew Sydes, senior medical statistician at the MRC Clinical Trials Unit, said: "Selecting men into treatment groups at random is the best way to ensure we can make a fair comparison. The trial is thoroughly explained to all men before they choose to take part."

About Prostate Cancer

In 2004 nearly 35,000 new cases of prostate cancer were diagnosed in the UK.

Prostate cancer causes 10,000 deaths in the UK each year

Prostate cancer is the most common cancer in men in the UK - it accounts for nearly a quarter - 24 per cent - of all new male cancer diagnoses.

Prostate cancer is quite rare in men under 50 years old. Around 60 per cent of prostate cancer cases occur in men aged 70 or over.

Signs and symptoms

The prostate enlarges as men get older and most men have some symptoms affecting urination. This very common condition, known as BHP (benign prostate hyperplasia), is not cancer. Many if the symptoms of prostate cancer are similar to those of BPH. Symptoms of prostate cancer include:

  • an urgent need to pass urine
  • passing urine more often and/or at night
  • difficulty in passing urine
  • pain while passing urine
  • blood in urine or semen
  • pain in the back, hips or pelvis.

The above symptoms may not be caused by cancer, but men who notice any of them should consult their doctor for advice on treatment, and to rule out prostate cancer.

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About the Medical Research Council

The MRC supports the best scientific research to improve human health. Its work ranges from molecular level science to public health medicine and has led to pioneering discoveries in our understanding of the human body and the diseases which affect us all. The Clinical Trials Unit (CTU) is a centre for clinical research which is supported by the Medical Research Council.

About the Institute of Cancer Research

The Institute of Cancer Research is Europe’s leading cancer research centre with expert scientists working on cutting edge research. It was founded in 1909 to carry out research into the causes of cancer and to develop new strategies for its prevention, diagnosis, treatment and care.

The Institute is a charity that relies on voluntary income. The Institute is one of the world’s most cost-effective major cancer research organisations with over 90p in every £ directly supporting research. For more information visit the ICR homepage.