ABOUT THE TRIAL

What are clinical trials?

Clinical trials are research studies involving patients, which compare a new or different type of treatment with the best treatment currently available (if there is one). No matter how promising a new drug or treatment may appear during tests in a laboratory, it must go through clinical trials before its benefits and risks can really be known. Trials aim to find out if treatments are safe, what side effects they have, and if they work better than the treatment used currently.

older man on computer
doctor talking to patient

Why are we running this trial?

One of the popular treatment options for low or intermediate risk prostate cancer is active surveillance. Active surveillance means, rather than treating men with surgery or radiotherapy, their doctor will monitor them for signs that their cancer is changing. Active surveillance is used because some prostate cancers never progress beyond the stage they are at when they are found, and so do not need further treatment. Active surveillance offers the opportunity to delay or avoid side effects associated with further treatments. These side effects can include incontinence (leakage of urine), erectile dysfunction, (trouble getting or keeping an erection), bowel issues, narrowing of the waterpipe in the penis, hernias, and wound and skin problems. 

  

Once active surveillance begins, men have regular tests to check on the cancer. One of the tests is a prostate specific antigen (PSA) test. This test measures the amount of PSA in their blood. PSA is produced by normal cells in the prostate and also by prostate cancer cells. A raised PSA level may suggest a problem in the prostate, but not necessarily cancer.  

  

PSA levels in men with prostate cancer can vary and can go up even when cancer is not progressing. Most men with low or intermediate risk prostate cancer do not require further treatment, but higher PSA levels may make men worry and this is a common reason why they may decide to have further treatment.  

  

We aim to improve what is offered for men on active surveillance so that they feel more confident in safely staying on active surveillance, using a drug called finasteride. 


Why do we think Finasteride will allow people to stay on active surveillance for longer?

Finasteride is used to improve symptoms of enlarged prostates, but also reduces PSA levels. We think that reducing PSA levels with finasteride might help clinicians assess prostate cancer more accurately by stopping it from rising due to factors that are not related to their prostate cancer (such as inflammation or normal enlargement associated with ageing). The decision regarding the need for further treatment will be more focused on the results of a prostate biopsy and prostate MRI, rather than fluctuating PSA levels. However, PSA levels will still be considered by their doctor because if their cancer is progressing, they can still rise, even if they are taking finasteride. 

Who is funding the FINESSE trial?

The trial is funded by Yorkshire Cancer Research, an independent charity dedicated to funding research so that you and those you love live longer, healthier lives. Their aim is for at least 2000 more people to survive cancer in Yorkshire every year. To do this, each year they fund £10 million of world-leading research to prevent, diagnose and treat cancer. 

Treatment Regimen

Consent and randomisation visit

Consent and random allocation to the study group can take place on the same day for men who have had a PSA test done in the last 3 months. Where an additional PSA test is needed, an extra visit or a trip to your GP may be necessary.

First year of the study

Research appointments will coincide with regular active surveillance appointments. No extra study appointments are required during this period. Men allocated to the treatment arm will also take one tablet of finasteride (5mg) every day during this year.


Second year of the study

During the second year of active surveillance, men are usually seen every 6 months in their regular Active Surveillance Clinic. Finesse study visits will continue to be scheduled every 3 months so participants will be asked to attend two extra

visits, one at month 15 and the other at month 21, during this period. Men in the treatment arm will continue to take one tablet of finasteride (5mg) every day during this year. The treatment will be stopped after two years.

Third, fourth and fifth year of the study

Men will continue to attend routine active surveillance appointments every 6 months and all study appointments will take place at the same time. Men allocated to the treatment arm will no longer take finasteride tablets during this period.


Questionnaires & Interviews

All men in the trial will be asked to complete questionnaires approximately every three

months, which should take between 20 and 30 minutes in total to complete. This is to check

how you are getting on, as we want to keep track of how your health and treatment may

affect your quality of life. These questionnaires will be emailed to you in between your visits.

For this reason, we will collect your personal contact details, with your permission.


Men who have consented to be contacted to take part in a telephone interview at the end of the trial will be invited to do so. Questions in this interview will relate to their experiences of taking part in the trial. The interview is optional.


What will the trial involve?

This is a randomised controlled trial, which means if you take part, you will be allocated to one of two study arms chosen at random. You and your medical team cannot choose which group you are put into. Half of the men will be placed into the active surveillance AND finasteride group (intervention arm) and half into active surveillance ONLY (control arm). We will recruit 550 men and allocate them to these groups. You and your doctor will both know which group you are in. This is what we call an ‘open label’ study. The study will run for five years, but if you are randomised to the intervention arm you will only take finasteride tablets for two of those years.

 

We are recruiting at NHS hospitals in England some of which may access patients at smaller district general hospitals via a 'Hub and Spoke' model. Please use the map on the 'Contact Us' page to contact your nearest site.


For more information about the Hub and Spoke model design of the study, please visit the 'What is a Hub and Spoke Model (HSM)?' section on the FAQs page.