TRANSFORM
Research type
Research Study
Full title
Trial of Randomised Approaches for National Screening FOR Men
IRAS ID
343441
Contact name
Hashim U Ahmed
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The TRANSFORM study will look at new ways of screening for prostate cancer, in what will be one of the biggest endeavours in prostate cancer in a generation. This will be a national randomised control trial and will provide the definitive data for policymakers to decide on whether screening for prostate cancer should be recommended. The study will provide data not only on the reductions in prostate cancer related mortality, but couple this with evidence of harm reduction, cost-effectiveness and deliverability within the UK healthcare system.
The study will be broken down into stages as follows:
Stage 1 will focus on making the trial run smoothly, testing a number of different possible screening approaches and also determine the best way to engage men in the community to take part in the study. Critically, it will also determine the best form of randomisation to carry out.
Stage 2 will take forward the most robust randomisation strategy and the most promising screening approach(es) with tens of thousands of consenting participants in order to prove that these new screening strategies are beneficial. During Stage 2 there will also be an in-depth analysis on the costs and cost savings of screening, resource and capacity requirements within the NHS to deliver an effective screening programme, as well as an evaluation of the potential challenges and barriers to the uptake of screening. This will mean that if and when screening is eventually recommended, we know how to maximise participation at a population level.
Alongside the study, we will set up a tissue collection (henceforth called TRANSFORM Discovery) which will facilitate rapid biomarker testing and other translational research efforts.
We will monitor the trial participants over the following 30 years to determine the long-term impact of screening on rates of disease progression and survival.
This REC & CAG application pertains only to Stage 1.
REC name
Wales REC 5
REC reference
25/WA/0197
Date of REC Opinion
24 Jul 2025
REC opinion
Favourable Opinion