Frequently asked questions & PIS

What is involved in taking part?

Men on active surveillance for prostate cancer are seen regularly in clinic. If you choose to join the study, we will ask you to continue to attend these appointments. Half the people joining the study will also be asked to take a finasteride tablet once a day for two years alongside their active surveillance appointments. 


We would like 550 people to join the study. Each person will be randomly put in either the group attending regular clinic appointments alone or the group taking a finasteride tablet once a day in addition to the regular clinic appointments. You will have an equal chance of being put into each groups. You will not be able to choose or change to the group you would prefer. 

Who can participate?

Men who:

  • Have opted for Active Surveillance for prostate cancer
  • Have been diagnosed with prostate cancer in the last 2 years
  • Have not received previous treatment for prostate cancer
  • Are fit and suitable for radical treatment
  • Are aged 50-75 years old at diagnosis

I am a transgender or non-binary person, can I still take part?

Yes. Whilst the terms ‘men’ and ‘male’ are used throughout the study documents, the trial is open to anyone with prostate cancer regardless of gender (including transgender women/non-binary), providing they satisfy the inclusion and exclusion criteria). 

What are possible benefits of taking part?

  • You may avoid or delay more intensive treatment for prostate cancer, which may have benefits for your quality of life.
  • The growth of your prostate cancer MAY be slowed down (with the drug), although further research is needed to see if this is definitely true, and this is not the main objective of the FINESSE study.
  • You may help improve the care of men with prostate cancer who opt for active surveillance and help us better manage the disease e.g., by promoting the use of other technologies in active surveillance such as MRI scans.
  • If you have benign disease in addition to prostate cancer, you may see improvements in this.
  • You will have more regular follow-ups than is standard practice. 

What are the side effects and will participating in the research affect my sex life?

As with all medicines, the drug used in this study, (finasteride) can cause side-effects. Some common side effects include less interest in having sex, trouble getting or keeping an erection, problems with ejaculating, such as little or no semen, breast tenderness & skin rash. These usually improve after a while, but they should be discussed with a doctor if they bother you or do not go away. Finasteride is widely prescribed for other conditions, e.g., benign prostate disease. 

Are there any alternative treatments to the study?

For men who have already made the decision to join an active surveillance programme, your alternative to this study is not to take part. There are alternatives to active surveillance which your doctor will have discussed with you, including surgery. However, if you are unsure what those alternatives are, or you would like to discuss them again, please ask your doctor, who will talk you through them in detail.

What if my prostate cancer progresses?

  • Your prostate cancer will be monitored closely. If your cancer progresses, your doctor may advise you to withdraw from the study. 

Will my taking part in the study be confidential?

In this study, most of the research team will not need to know your name. In these cases, someone will remove your name from the research data and replace it with a code number. This is called coded data, or the technical term is pseudonymised data. For example, your blood test might be labelled with your code number instead of your name. It can be matched up with the rest of the data relating to you by the code number. In the FINESSE study, this code number is called a Patient Identification Number (PIN). Your PIN will be used on all your study records and samples instead of your name to ensure information is kept confidential. Your medical records may be looked at by people who are authorised to check that the study is being carried out properly, and the quality of the research.


Representatives of health regulatory authorities and the hospital NHS Trust, and auditors from the Trials Unit and Sponsor may have access to your medical records, and these people will be required to keep your information confidential. A responsible representative from King’s College London will also require access to records for the purpose of monitoring and auditing. By signing the consent form you are giving your permission for this to happen.


Your contact details and information collected about you will be stored on a secure database, and access will only be available to members of the trial team, other members of King’s College London who may wish to monitor the study, and a third party based outside of the UK who will send text messages on our behalf. These details will also be required to send you study related information questionnaires, and to allow the study team to collect registry data during passive follow-up. Your personal identifiable data will never be stored outside of the UK.

Can I withdraw from the study?

  • You can stop taking part in the study at any time without giving a reason. This will not affect the healthcare you receive in any way. You will continue to receive standard healthcare. You may wish to continue helping with the trial, by filling in occasional questionnaires to let us know how you are doing, but this will be optional. 

What is a Hub and Spoke Model (HSM)?

  • In this study we have decided to introduce an additional way of recruiting patients called a Hub and Spoke model. The hubs are usually large hospital trusts, which act as the main sites conducting research such as the FINESSE trial. We call these main sites ‘investigator sites’. Spokes are smaller district general hospitals within reach of the hub, which help hubs meet the aims of the FINESSE study. For example, if Sheffield NHS Hospital Trust acted as a hub for this study, smaller District General Hospitals located nearby might act as spokes.
  • If you are receiving care for your prostate cancer at a hospital which has agreed to help with recruitment for the FINESSE trial by enrolling as a ‘Spoke’ site within the trial HSM design, your type of prostate cancer and treatment makes you suitable for the FINESSE trial and you are thinking of joining the trial, you will be given additional information before you make your decision.
  • For further information, please read the patient information sheet HSM addendum here.

Patient Information Sheet

For further information, please read the patient information sheet which can be found here.

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