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FINESSE trial - What to help shape the work?

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Posted 15 Feb 2021 at 10:22

FINESSE trial: a study evaluating the role of Finasteride among men with prostate cancer on active surveillance

Opportunity to be involved in shaping this trial - YOU WILL NOT BE ON THE TRIAL ITSELF

Many prostate cancers are not lethal and can be safely managed by observation (Active Surveillance). Over time, more than half of the men choosing observation receive radical surgery or radiotherapy. Both treatments produce side-effects and may be unnecessary. Most men opt for treatment because of their rising PSA (prostate blood test) levels. This usually reflects aging of the prostate, rather than advancing cancer.

We aim to improve what is offered, so more men remain on observation. We believe a drug called Finasteride may help. Finasteride slows prostate growth and reduces PSA levels. Finasteride has few side-effects and has been shown to reduce the risk of a man developing prostate cancer. We will randomise 550 men receiving observation for low/intermediate risk prostate cancer to either finasteride or usual care. All men will receive Active Surveillance, including PSA testing (3 monthly year 1 and 6 monthly years 2/3) and MRI scanning (at year 1 and 3). Prostate biopsies will be used for men with changing MRI scans and at year 3. We predict that finasteride will reduce the number of men receiving radical treatment from 20% to 10% at 4 years.

 

This research is funded by Yorkshire Cancer Research, and will take place in Leeds, Sheffield, London, and potentially other sites across the UK.

 

What would be involved? 

We are seeking 3 men to become members of the committees that support the running of the trial. Participation in these committees is likely to be remote via video conferencing software such as Zoom. There may be opportunities for travel in the future, but we will discuss that with you closer to the time.

  • We would like 1 man to join our trial management group, which starting in April will meet every month for the next 6 years. This group is responsible for advising on the day to day running of the trial and supporting the main investigators regarding some of the decisions they must make about study design and delivery. They will be renumeration for every meeting they are able to attend.
  • We would like 2 men to join our trial steering committee, which will meet every 6 months for the next 6 years. This group are responsible for holding the investigators to account, and ensuring the men participating in the trial are treated ethically and safely. They are an independent group, led by an external scientist. This individual will be renumerated for every meeting they are able to attend.

Who would we like to speak with?

We are seeking men with prostate cancer who meet the following criteria:

  • Diagnosed with prostate cancer in the last 5-10 years
  • Has experience with observation (also called active surveillance) after diagnosis
  • (Desirable, not essential) Experience of active surveillance followed by radical treatment
  • We would particularly like to invite black men to work with us, as this is a disease particularly common among these ethnic groups.

I am interested, what next?

 

If you are interested in this opportunity, please email Dr Sam Smith (s.smith1@leeds.ac.uk) by March 1st, 2021 with some answers to the following questions:

 

Can you tell us why you meet the criteria above for the men we’d like to speak with?

 

Which role would you be most interested in (trial management group, trial steering committee or both?)

 

What experience do you have in participating in working group meetings?

 
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