Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Jim Catto
+44 (0)114 215 9002
j.catto@sheffield.ac.uk


Ms Roseann Kealy
+44 (0)20 7848 9705
r.kealy@qmul.ac.uk


Dr Finesse Study Team
-
cptu-finesse@qmul.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - A randomised phase 3 trial evaluating the role of finasteride in increasing compliance with active surveillance, in men with a new diagnosis of low and intermediate risk prostate cancer, when compared with usual care.

A randomised phase 3 trial evaluating the role of finasteride in increasing compliance with active surveillance, in men with a new diagnosis of low and intermediate risk prostate cancer, when compared with usual care.

Recruiting

Open to: Male

Age: Mixed

Medical Conditions

Men with a new diagnosis of low- and intermediate-risk prostate cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Prostate cancer is cancer that occurs in the prostate. The prostate is a small walnut-shaped gland in males that produces the seminal fluid that nourishes and transports sperm.
Prostate cancer is the commonest cancer in men. 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 predict that finasteride will reduce the number of men receiving radical treatment from 20% to 10% at 4 years.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Aug 2022 30 Sep 2025

Publications

2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39933820/ (added 13/02/2025)

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.


Men aged 50 – 75 years who are receiving observation for low/intermediate-risk prostate cancer

You can take part if:



You may not be able to take part if:


1. Those not fit for radical treatment2. Those who have previously received treatment for prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)3. Whose life expectancy is < 10 years4. Either current or recent (≤12 months) treatment with finasteride or dutasteride5. Currently enrolled or has been a participant within the last 30 days, in any other investigational drug or device study6. Men not willing to comply with the procedural requirements of this protocol7. Known allergy/sensitivity to, or intolerance of, finasteride or other 5-alpha reductase inhibitors, e.g., dutasteride. Known allergy to any excipients of finasteride8. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years9. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous10. All contraindications to finasteride including concomitant therapy with any medication that may interact with finasteride11. Any rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption12. Men trying for a baby or with a pregnant partner


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leeds Teaching Hospitals NHS Trust
    Great George street
    Leeds
    LS1 3EX
  • Royal Hallamshire Hospital
    Sheffield Teaching Hospitals NHS Foundation Trust Glossop Road
    Sheffield
    S10 2JF
  • Mid Yorkshire Teaching NHS Trust
    Pinderfields Hospital Aberford Road
    Wakefield
    WF1 4DG
  • Churchill Hospital Cancer Centre
    Old Road
    Oxford
    OX3 7LE
  • Bradford Teaching Hospital
    Duckworth Lane
    Bradford
    BD9 6RJ

Benefits: Participants may benefit from the medication used
Risks: Potential participants will be informed of all the possible risks associated with taking finasteride, and they will also be documented in the Patient Information Leaflet (PIS). Common side effects: Impotence, Decreased libido, Decreased volume of ejaculate

Dr Finesse Study Team
-
cptu-finesse@qmul.ac.uk


Prof Jim Catto
+44 (0)114 215 9002
j.catto@sheffield.ac.uk


Ms Roseann Kealy
+44 (0)20 7848 9705
r.kealy@qmul.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by Yorkshire Cancer Research.




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Read full details for Trial ID: ISRCTN16867955
Last updated 13 February 2025

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