FINESSE
Research type
Research Study
Full title
The FINESSE Study: 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.
IRAS ID
1004290
Contact name
James Catto
Contact email
Sponsor organisation
Sheffield Teaching Hospital NHS Foundation Trust (STHNFT)
Eudract number
2021-004004-17
ISRCTN Number
ISRCTN16867955
Research summary
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 will randomise 550 men receiving observation for low/intermediate risk prostate cancer to either finasteride 1 x 5mg tablet per day, 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. Participants randomised to take finasteride will receive the treatment for 2 years. All participants will be followed up for an average of 4 years.
We predict that finasteride will reduce the number of men receiving radical treatment from 20% to 10% at 4 years. The study is funded by Yorkshire Cancer Research and so participants will predominantly be recruited from Yorkshire’s urological centres, although non-Yorkshire centres will be included (to speed up recruitment).REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0349
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion