A trial to find the best timing for brachytherapy and external radiotherapy for prostate cancer (THEPCA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Other

This trial is to find out if it is best to have high dose rate brachytherapy before or after having external radiotherapy for prostate cancer. The trial is open to men with prostate cancer that is contained within the prostate gland or has spread to the seminal vesicles Open a glossary item only (localised Open a glossary item prostate cancer).

More about this trial

Doctors can use the combination of external beam radiotherapy and high dose rate brachytherapy to treat localised prostate cancer.

External beam radiotherapy uses high dose radiation to the prostate gland.

High dose rate brachytherapy is a type of internal radiotherapy. Doctors put fine plastic tubes containing a highly radioactive Open a glossary itemsubstance into the prostate through the skin between your testicles and your back passage (rectum) into the prostate gland. After a short period of time the tubes and substance are removed.

Some doctors use external beam radiotherapy followed by high dose brachytherapy and others use high dose brachytherapy followed by external radiotherapy. But it isn’t known if it is better to have external radiotherapy first or high dose rate brachytherapy. 

In this trial half the men will have external beam radiotherapy followed by high dose rate brachytherapy and the other half will have high dose rate brachytherapy followed by external beam radiotherapy.

The researchers want to compare the side effects of having external beam radiotherapy first followed by high dose rate brachytherapy with having the treatments the other way round.

Who can enter

You may be able to join this trial if you go to the Southend hospital and you

  • Have prostate cancer that is contained in your prostate gland or that has spread to the seminal vesicles Open a glossary item(stage T1 to T3b)
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have prostate cancer that has spread to another part of your body
  • Have had surgery to remove the inner part of your prostate gland (TURP)
  • Have had laser surgery to your prostate (HoLEP)
  • Have had any radiotherapy to the area between your hip bones (pelvis)
  • Have severe urinary symptoms caused by your prostate cancer (your doctor can advise you about this)
  • Have an abnormal opening (fistula Open a glossary item) into your back passage (rectum)

Trial design

This is a feasibility trial. The researchers need 50 men to join.

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

  • Men in one group have external beam radiotherapy followed by high dose rate brachytherapy
  • Men in the other group have high dose rate brachytherapy followed by external beam radiotherapy

Your doctor will need to plan your treatment before having external beam radiotherapy. This is to plan where to give the treatment and how much to give. You have a planning CT scan which shows where the cancer is. This can take up to a couple of hours.

For your external beam radiotherapy, you go to the hospital Monday to Friday for 4½ weeks.

You doctor will also plan your treatment for high dose rate brachytherapy. This is done immediately before having treatment. For the planning you follow a special diet for 24 hours before to make sure your bowel is empty. Your doctor will use a transrectal ultrasound to find the exact size and shape of the prostate gland.

Before treatment you have a drug that stops feeling, especially pain (an anaesthetic Open a glossary item). The doctor puts thin tubes through the skin behind your testicles and your back passage (rectum). These tubes will be attached to a high dose rate brachytherapy machine. Radioactive substance will go from the machine through the thin tube to your prostate. After a certain amount of time when the treatment is completed the radioactive substance and tubes are removed. So there is no radioactive material left in your body. Once you have recovered from your anaesthetic and passed urine normally without any problem you can go home.

You will also have hormone therapy alongside the radiotherapy and brachytherapy. You doctor will talk to you about this and about how long you need to take the hormone therapy.

The trial team will ask you to fill out a questionnaire before you start treatment, at 3 months, 9 months and a year after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part. These tests include

  • A physical examination
  • Blood tests

After you have completed both radiotherapy and brachytherapy you see the doctor for a physical examination and blood tests at

  • 6 weeks
  • 3 months
  • 6 months
  • 9 months
  • 12 months

Side effects

The side effects of having external beam radiotherapy and high dose rate brachytherapy are similar and include

  • Bladder inflammation
  • Diarrhoea
  • Sore skin in the genital area
  • Loss of pubic hair
  • Difficulty passing urine
  • Problems getting an erection
  • Frequent or loose bowel movements
  • Inflammation of the back passage

We have information about the side effects of prostate cancer radiotherapy.

Your doctor will talk to you about the possible side effects of all the treatments used in this trial before you agree to take part.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Imtiaz Ahmed

Supported by

Anglia Ruskin University
Southend University Hospital NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13305

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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