IP9 – ATLAS (Approaches To Long-Term Active Surveillance)
Research type
Research Study
Full title
A randomised controlled trial of regular MRI scans compared to standard care in patients with prostate cancer managed using active surveillance
IRAS ID
328263
Contact name
Hashim U. Ahmed
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
8 years, 7 months, 30 days
Research summary
Aims
To show that regular MRI scans can better detect prostate cancer worsening than standard care in patients on active surveillance.Background
Two NICE and 3 James Lind Alliance research priorities for prostate cancer relate to improving active surveillance.
Every year, ~7,600 patients with low-medium risk prostate cancer choose active surveillance rather than treatment. This is because these cancers are slow growing and treatments can cause side-effects. A quarter of cancers progress to higher risk over 5 years. For active surveillance, NICE recommends prostate specific antigen (PSA) blood tests and rectal exams every 3-6 months. After 1 year, PSA and rectal exams every few months and a biopsy if PSA increases or the prostate feels abnormal. This has problems. First, half the cancers that progress are detected late. Second, many patients have unnecessary repeat biopsies which carries risks of infection, pain and bleeding. Repeat biopsies and anxiety lead 10-40% of patients deciding to have treatment unnecessarily.Evidence suggests that regular MRI scans are more accurate at detecting progression but a definitive clinical trial is required.
Design
We will conduct an RCT in 30 UK centres recruiting from diverse (ethnic, socio-economic, vulnerable) groups using accessible patient materials in 5 languages in written, visual and video formats. After consent, patients with localised prostate cancer who have chosen active surveillance will be randomly allocated to either NICE defined surveillance or regular MRI based surveillance. In the intervention group, suspicious changes on MRI will require a targeted biopsy. The primary outcome will be progression in each group defined as higher risk cancer on biopsy or cancer spread over 5 years. We will also measure number having MRI, biopsies and cancer treatment, complications and side-effects, and patient reported outcome measures on health-related quality-of-life, anxiety, urinary, sexual and
bowel function. The costs and cost savings for the NHS will be measured.REC name
Wales REC 7
REC reference
23/WA/0323
Date of REC Opinion
14 Dec 2023
REC opinion
Further Information Favourable Opinion