A trial looking at finasteride and active surveillance for newly diagnosed prostate cancer

Cancer type:

Prostate cancer

Status:

Open

Phase:

Phase 3

This trial is looking at whether finasteride can help some men with localised prostate cancer have active surveillance for longer.

It is for men who are going to have active surveillance after being diagnosed with localised prostate cancer.

More about this trial

Prostate cancer is cancer that starts in the prostate gland. It is the most common cancer in men in the UK.

Doctors may describe prostate cancer as localised, locally advanced and metastatic. Localised prostate cancer is cancer that is completely inside the prostate gland. It hasn’t spread outside the prostate gland or to any other part of the body.

You may also hear your doctors dividing prostate cancer into groups depending on how likely it is that the cancer will grow quickly or spread. These are called risk groups. They divide localised prostate cancer into 3 risk groups:

low risk
intermediate risk
high risk

Treatment for localised prostate cancer depends on a number of things including your risk group. For low and intermediate risk prostate cancer, you might not have treatment straight away. Your doctor might suggest monitoring your cancer closely and you have treatment if it starts to grow. This is active surveillance. As part of active surveillance, you have blood tests to monitor your PSA level.

Researchers in this trial want to find out if a drug called finasteride can help men to continue with active surveillance for longer.

Finasteride is a drug that can stop the hormone Open a glossary item testosterone from turning into another hormone called dihydrotestosterone. Prostate cancer usually depends on testosterone to grow. So doctors think finasteride can help to stop prostate cancer from growing. Finasteride is already a treatment for men with benign prostatic hyperplasia (BPH).

Everyone taking part in this trial has 1 of the following:

active surveillance and finasteride
active surveillance alone

Some of the aims of this trial are to:

find out if finasteride can help some men with localised prostate cancer to have active surveillance for longer
learn about the quality of life of men taking finasteride

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 have low or intermediate risk adenocarcinoma of the prostate (prostate cancer)
you have been diagnosed with prostate cancer in the last 6 months
your prostate cancer grade group is 1 or 2. This is also called the Gleason score.
your prostate cancer has a TNM staging of T2b N0 M0 or lower. Your doctor can tell you more about this.
you have decided to have active surveillance
you are well enough to have radical treatments such as radiotherapy or surgery
your PSA level is 20ng/ml or lower
your PSA density is 0.2 ng/ml or lower
you are aged between 50 and 75
you are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1)

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

have had treatments such as radiotherapy, surgery or hormone therapy for prostate cancer
have had finasteride or dutasteride in the past year
are taking part or took part in another clinical trial in the last month looking at a new drug or device
are sensitive to finasteride or any other similar drugs
have any other medical condition that the trial team think would affect you taking part
have had another cancer in the past 5 years apart from non melanoma skin cancer
have a rare condition that affects the way you absorb galactose or lactase
are trying to have a baby or your partner is pregnant

Trial design

This is a phase 3 trial. Researchers hope that around 550 men in the UK will agree to take part.

This trial is randomised. The people taking part are put into 1 of the following groups by a computer:

active surveillance and finasteride
active surveillance alone

Neither you nor your doctor will be able to decide which group you are in.

Diagram 1

Active surveillance and finasteride
You have regular tests to check your cancer. The tests you have include a blood test to check your PSA level every 3 to 6 months. You may also have a type of MRI scan called multiparametric MRI scan (mpMRI) at 1 and 3 years after the start of this trial.

You also take finasteride. These come as tablets that you take every day, for 2 years.

You may also have a sample of tissue taken (a transperineal biopsy) 3 years after the start of this trial. Your doctor can tell you more about this. It depends on the results of your mpMRI scan.

Active surveillance alone
You have the same tests as you would if you weren’t taking part in this trial (the standard treatment Open a glossary item ). The tests that you have include a blood test to check your PSA level every 3 to 6 months. You may also an mpMRI scan 1 and 3 years after the start of this trial.

Quality of life questionnaires
Everyone taking part completes quality of life questionnaires. They ask about how you have been feeling and what side effects you have had. They take about 20 minutes to complete each time.

You complete the questionnaires:

before the start of treatment
every 3 months for 2 years
then every year for 3 years

Telephone interview
The trial team may ask you to take part in a telephone interview at the end of this trial. The interview takes around an hour. The trial team will ask about your experience of taking part in this trial.

You don’t have to agree to have an interview if you don’t want to. You can still take part in the trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

blood tests
a physical examination including an examination of your prostate (a digital rectal exam)
an mpMRI scan

You see the trial doctor at set times during the trial. Where possible, you see them at the same time you are at the hospital for tests and appointments that are part of your normal care. In total, you might have 2 extra hospital visits as part of this trial.

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 finasteride are: