A trial of active surveillance and apalutamide for prostate cancer (TAPS01)

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:

Phase 2

This trial is looking at a drug called apalutamide alongside regular monitoring for prostate cancer. It is for men whose cancer is contained within the prostate gland (localised prostate cancer).

More about this trial

Prostate cancer can grow so slowly that it never causes any symptoms. So, some men with localised prostate cancer have regular monitoring instead of immediate treatment. This is called active surveillance. It means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, then you and your doctor will decide which treatment is best for you. We know however that over time some of these cancers may start to grow and become worse.

Apalutamide is a new type of hormone therapy. Hormone therapy is one of usual treatments for prostate cancer. It reduces the amount of testosterone Open a glossary item in the body and blocks it from reaching the cancer cells. This can shrink a prostate cancer or slow its growth.

In this trial, researchers want to find out if it can shrink the size of the tumours in men having active surveillance by giving them a short duration treatment with apalutamide. The researchers hope this will reduce the chance of the cancer getting worse and needing any treatment in the future.

The aims of this trial are to find out:

  • how willing men are to take part
  • how well treatment works for prostate cancer that has a low risk of growing or spreading

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this trial if all of the following apply.

You:

  • have prostate cancer that has a low to medium risk of growing or spreading
  • have prostate cancer that the doctor can see on a scan and they took tissue samples (biopsies) Open a glossary item from the tumour
  • are having regular check ups (active surveillance) to monitor the prostate cancer
  • started active surveillance at least 6 months ago and it has been at least 6 months since the doctors took a tissue sample from your prostate
  • are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • are willing to use 2 forms of reliable contraception during the trial and for 3 months afterwards if there is any chance your partner could become pregnant
  • have satisfactory blood test results
  • are at least 18 years old

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You:

  • have had previous treatment for prostate cancer including radiotherapy, hormone therapy, brachytherapy Open a glossary item or surgery
  • have prostate cancer that has grown since your last MRI scan
  • can’t have apalutamide for any reason
  • are taking part in another clinical trial with an experimental treatment
  • are having treatment for another cancer

Medical conditions
You:

  • can’t have an MRI scan for any reason for example you have a pacemaker, an implant to help you hear or you have a fear of small spaces (claustrophobia)
  • have a problem with your digestive system Open a glossary item that would affect how you absorb the trial drug
  • are taking medication that increases the chance of you having a fit (seizure)
  • have a problem with your thyroid Open a glossary item that isn’t controlled with medication
  • have any other medical condition or mental health problem that the trial team think could affect you taking part

Other
You:

  • are allergic to apalutamide or any of its ingredients
  • can’t have contrast medium Open a glossary item that helps make a scan clearer
  • have any metal implants in the area between your hip bones (pelvis)

Trial design

This is a pilot phase 2 trial. The researchers hope at least 10 men will take part. It is for men having treatment at Addenbrooke’s Hospital in Cambridge. This pilot trial will help the trial team to check whether the treatment works enough to run a future larger trial.

You take apalutamide tablets every day for 90 days. The trial team will give you a supply of tablets that you take at home. They will tell you when to start taking them. The research nurse will call you on the day you start treatment and then every 2 to 3 weeks to see how you are getting on. You keep a diary to note down when you take them.

Quality of life
The trial team will ask you to fill out 2 short questionnaires before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This part of the study is called quality of life Open a glossary item.

Hospital visits

You see a doctor and have some tests before you can take part in the trial. These include:

  • physical examination
  • blood tests
  • MRI scan

You see the trial team and have some blood tests at:

  • 1 month
  • 2 months
  • 3 months

You have an MRI scan when you finish treatment. This will be used to compare the size of the tumour with the first scan, to see if the tumour has shrunk.

You see the trial team 4 to 6 weeks after you finish treatment for a check up. You then continue with your routine hospital appointments.

Side effects

As apalutamide is a new drug there might be side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call them if you are worried about anything.

So far, the most common side effects include:

  • tiredness (fatigue)
  • skin rash
  • joint pain
  • weight loss
  • risk of falls
  • bone fractures

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

Mr Vincent Gnanapragasam

Supported by

Cambridge University Hospitals NHS Foundation Trust
Cambridge Clinical Trials Unit
Janssen-Cilag
University of Cambridge

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15423

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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