A trial looking at short term apalutamide for early intermediate risk prostate cancer (TAPS02)
Cancer type:
Status:
Phase:
This trial is looking at using apalutamide to slow down the growth of prostate cancer.
It is open to men whose early prostate cancer is being managed by active surveillance. And who have a higher risk of their cancer getting worse.
More about this trial
Men diagnosed with early prostate cancer might not need active treatment straight away. For these men the doctor would suggest active surveillance. This means they are closely monitored and if their cancer gets to a certain stage the doctor will recommend active treatment.
Doctors know that some men on active surveillance have a high risk of their cancer getting worse. Doctors work this out by looking at detailed information about the cancer including:
- the Cambridge Prognostic Group (CPG)
- the Grade Group
- whether they can see any cancer on an
MRI scan 
Apalutamide is a . Doctors already use it as a treatment for more prostate cancer. It works by blocking a hormone called . Prostate cancer needs testosterone to grow. Blocking its effects can help slow the growth of the cancer.
Researchers carried out a small study called TAPS01. The results of this study showed that a short treatment course of apalutamide might help men with early prostate cancer who are managed by active surveillance.
In this trial, the team want to find out if this is also the case for a larger number of men whose cancer has a higher chance of getting worse. They also want to find out how long people should have apalutamide to get the most benefit. Everyone in this trial will have apalutamide, but some men may have it for different lengths of time.
The aims of this trial are to find out:
- how well a short course of apalutamide works in slowing down the growth of cancer in this group of men
- whether a short course of apalutamide means that fewer men will need treatment, such as surgery or radiotherapy, which may cause long term side effects
- the best length of time to have apalutamide
- more about the side effects
- how apalutamide affects
quality of life
Who can enter
The following bullet points are a summary of 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:
- are having monitoring of your cancer with active surveillance
- have prostate cancer that is a Cambridge Prognostic Group (CPG) 2 with Grade Group 2 on your biopsy report. Your doctor will know about this.
- have had an MRI scan that shows you have an abnormal area in the prostate gland and this is PIRADs or Likert score of 4 or 5. You might also be able to join if the Likert score is 3 and the abnormal area cancer is more than 10 mm. Or you may be able to join if you have CPG1 with a high PSA density and a Likert score 4 or 5. Your prostate cancer specialist team will know about all of this.
- are able to look after yourself but might not be able to work (performance status 0, 1 or 2)
- have satisfactory blood test results
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of the following apply. You:
- are having any treatment for prostate cancer. This includes
anti androgen drugs - have any metal in your body that can affect the reading of a prostate
MRI scan or you are not able to have an MRI scan. Your doctor will know about this. - are having treatment as part of another clinical trial
- have prostate cancer that is CPG1 with a low PSA density and an MRI Likert score of 3 or less, or you have both
- are expected to have surgery to your prostate to help with urinary symptoms within the next 18 months
Medical conditions
You cannot join this trial if any of the following apply. You:
- have had a seizure (fit) or you have a medical condition that makes you more likely to have had a seizure within the past year
- are taking medication that means you are more likely to have a seizure within the month before being put into a treatment group (r
andomisation ). This is unless you can stop the medication or take another instead. - have had a history of recurrent falls in the past or are at high risk of falls due to other medical conditions
- have a higher than normal risk of breaking your bones (fractures) than the general population
- have
heart problems that could affect you taking part - are taking certain medication. Your doctor will know which medications these are.
- have a
digestive system problem that means your body cannot normally absorb medication very well - have symptoms that suggest you might have a severe skin reaction to medication such as Steven Johnston’s syndrome (SJS) or toxic epidermal necrolysis (TEN). Your doctor will know this.
- are allergic or sensitive to apalutamide or any of its ingredients
Trial design
This is a phase 3 trial. There are 2 parts to this trial:
- a pilot study
- the main trial
Both parts are randomised. A computer puts you into a treatment group. Neither you nor your doctor can choose which group you go into.
Pilot study
In this pilot study, the team want to find the best length of time for apalutamide treatment. They need 90 people to take part. There are 3 groups in this part. The groups are:
- 6 months of apalutamide
- 6 months of a dummy drug (
placebo ) - 3 months of apalutamide followed by 3 months of the dummy drug
The main part of the trial will open once the team have found out how long people should take apalutamide for.
Those who take part in the pilot study will also be included in the main trial.
Main trial
In this part, the team need up to a further 372 people to join making a total of 402 in the whole trial.
When this part opens we will update this summary.
You have apalutamide and the dummy drug as tablets. You take 4 tablets once a day.
Quality of life
You fill in questionnaires:
- before starting treatment
- at regular times during treatment
- at regular times for up to a year after treatment
The questions ask about:
- your general health
- any side effects or symptoms
- what daily activities you can do
These are quality of life questionnaires.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- MRI scan
A member of the trial team will phone you on the first day and day 15 to make sure you have the tablets and are fine with taking them.
You see the doctor every 3 months during treatment and at the end of treatment. This is to see how you are and for blood tests.
After treatment, you then see the doctor at:
- 6 months
- 1 year
- 2 years
- 3 years
You have an MRI scan at:
- the end of treatment
- 1 year after treatment
- 3 years after treatment
You have a sample of the prostate () taken at 3 years after treatment.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of apalutamide are:
- tiredness (fatigue)
- skin rash
- high blood pressure
- hot flushes
- joint pain
- loss of appetite
- diarrhoea
- weight loss
- fractures
- falls
We have more information about apalutamide.
Your doctor will talk to you about the possible side effects and answer any questions you may have before you agree to take part.
Location
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.
Chief Investigator
Professor Vincent Gnanapragasam
Supported by
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
