The Imperial Prostate 9 - Approaches To Long-term Active Surveillance: regular MRI scans versus standard of care (IP9-ATLAS) randomised controlled trial
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Introduction and objectives
Active surveillance is heterogenous using combinations of prostate specific antigen (PSA), digital rectal exam (DRE), magnetic resonance imaging (MRI) and biopsy. Using serial prostate MRI scans during active surveillance to inform when to conduct repeat biopsies might be effective to balance the burden of testing and detecting cancer progression early. IP9-ATLAS aims to determine whether regular MRI scans during active surveillance, compared to current standard of care (clinically-indicated MRI scans), will improve detection of cancer progression over 5 years.
Methods
IP9-ATLAS is a prospective, multi-centre RCT including patients with a histological diagnosis of Grade Group 1 or 2 disease on active surveillance. It compares UK NICE-defined standard of care (regular PSA and DRE when indicated with clinically-guided use of repeat MRI and biopsy), against the intervention arm (regular PSA and regular prostate MRI scans without intravenous contrast medium (i.e. biparametric), planned yearly for patients with an MRI-visible cancer lesion or Grade Group 2 cancer and every 2 years for all other patients). An internal pilot will determine the feasibility of the trial. 1263 patients will be recruited. Ethics committee approval has been granted by the Health Research Authority Research Ethics Committee Wales.
Results
The primary outcome is cancer progression rate, defined as higher risk cancer on biopsy (Grade Group ≥3) or a higher stage (≥T3 or ≥ N or ≥ M1) over 5 years. Secondary outcomes will include treatment rates without progression, adverse events, cost-effectiveness and functional outcomes. Recruitment started in May 2024 and is due to complete in June 2027, with follow-up until 2032. The trial is registered with the ISRCTN and Clinical Trials.gov (ISRCTN11447662 / NCT06280781).
Conclusion
IP9-ATLAS aims to provide robust level 1 comparative data to improve active surveillance protocols and change practice.
Active surveillance is heterogenous using combinations of prostate specific antigen (PSA), digital rectal exam (DRE), magnetic resonance imaging (MRI) and biopsy. Using serial prostate MRI scans during active surveillance to inform when to conduct repeat biopsies might be effective to balance the burden of testing and detecting cancer progression early. IP9-ATLAS aims to determine whether regular MRI scans during active surveillance, compared to current standard of care (clinically-indicated MRI scans), will improve detection of cancer progression over 5 years.
Methods
IP9-ATLAS is a prospective, multi-centre RCT including patients with a histological diagnosis of Grade Group 1 or 2 disease on active surveillance. It compares UK NICE-defined standard of care (regular PSA and DRE when indicated with clinically-guided use of repeat MRI and biopsy), against the intervention arm (regular PSA and regular prostate MRI scans without intravenous contrast medium (i.e. biparametric), planned yearly for patients with an MRI-visible cancer lesion or Grade Group 2 cancer and every 2 years for all other patients). An internal pilot will determine the feasibility of the trial. 1263 patients will be recruited. Ethics committee approval has been granted by the Health Research Authority Research Ethics Committee Wales.
Results
The primary outcome is cancer progression rate, defined as higher risk cancer on biopsy (Grade Group ≥3) or a higher stage (≥T3 or ≥ N or ≥ M1) over 5 years. Secondary outcomes will include treatment rates without progression, adverse events, cost-effectiveness and functional outcomes. Recruitment started in May 2024 and is due to complete in June 2027, with follow-up until 2032. The trial is registered with the ISRCTN and Clinical Trials.gov (ISRCTN11447662 / NCT06280781).
Conclusion
IP9-ATLAS aims to provide robust level 1 comparative data to improve active surveillance protocols and change practice.
Date Issued
2026-06-01
Date Acceptance
2026-04-11
Citation
Contemporary Clinical Trials, 2026, 165
ISSN
1551-7144
Publisher
Elsevier BV
Journal / Book Title
Contemporary Clinical Trials
Volume
165
Copyright Statement
© 2026 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/41990428
PII: S1551-7144(26)00094-7
Subjects
Active surveillance
MRI
Prostate biopsy
Prostate cancer
Prostate specific antigen
cancer progression
Publication Status
Published
Coverage Spatial
United States
Article Number
108308
Date Publish Online
2026-04-15