Clinical trial · Interventional
Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
A Randomised Controlled Trial of Regular MRI Scans Compared to Standard Care in Patients With Prostate Cancer Managed Using Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy. Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)? Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI Scans | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care (Control) Arm
- description
- PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually if clinically indicated. MRI will be carried out at 12 months (if not had one at diagnosis). If a diagnostic MRI was carried out, a 12 month MRI scan will not be required. A biopsy will be required if indicated due to changes in rectal exam or PSA. Follow-up for 5 years.
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI scans annually. As per international PIRADS committee guidance the surveillance MRIs will be biparametric MRI scans which last approximately 15 minutes and exclude gadolinium contrast injection. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4.
- interventionNames
- Diagnostic Test: MRI Scans
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or above (no upper limit) * Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all). * Diagnostic bi-parametric or multiparametric MRI * Diagnostic systematic biopsy +/- targeted biopsy * A histological diagnosis of localised prostate cancer * Patient chosen active surveillance Exclusion Criteria: * On active surveillance for greater than 9 months prior to screening date. * Contraindication to MRI or gadolinium contrast * Previous hip replacement to both hips * Contraindication to performing a biopsy guided by a transrectal ultrasound probe
References
Publications (1)
- DERIVEDGopalakrishnan A, Light A, Mayor N, Cullen E, Rawlins F, Dalton R, Tanaka MB, Connor MJ, De Dios CC, Fiorentino F, Ali A, Akinyemi I, Klimowska-Nassar N, Sasikaran T, Monk R, Baker G, Andrews M, Sculpher M, Rothery C, Barrett T, Mangar S, Freeman A, Winkler M, Heer R, Shah TT, Sokhi HK, Giganti F, Punwani S, Emberton M, Ahmed HU. The Imperial Prostate 9 - Approaches To Long-term Active Surveillance: Regular MRI scans versus standard of care (IP9-ATLAS) randomised controlled trial. Contemp Clin Trials. 2026 Jun;165:108308. doi: 10.1016/j.cct.2026.108308. Epub 2026 Apr 15. PMID 41990428