Study Comparing Regular MRI Scans to Standard Care for Men on Active Surveillance of Low to Medium Risk Prostate Cancer
Led by Imperial College London · Updated on 2026-03-30
1263
Participants Needed
12
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether regular MRI scans can better detect progression in patients on active surveillance for low to medium risk prostate cancer compared to the current standard care defined by NICE. The study aims to see if MRI scans reduce the number of PSA tests, biopsies, and clinic visits over five years while improving cancer progression detection. This trial involves patients who have chosen active surveillance and have a histological diagnosis of localized prostate cancer.
Participants are randomly assigned to one of two groups. The standard care group will have PSA tests every 3 months in the first year, then every 6 months with annual rectal exams when clinically indicated, and an MRI at 12 months if not done at diagnosis. Biopsies occur if PSA or rectal exams indicate changes. The intervention group will have PSA tests every 6 months and regular MRI scans annually for patients with visible lesions or medium risk cancer, or in years 1, 3, and 5 for others. Targeted biopsies are performed if MRI PRECISE scores are 4 or higher. The MRI scans are biparametric and do not use gadolinium contrast.
Participants will be followed for five years with regular PSA tests, MRI scans, biopsies when indicated, and clinical assessments. Researchers will monitor biopsy and staging results, cost-effectiveness, adverse events related to MRI and biopsies, treatment decisions, compliance, and quality of life using questionnaires on prostate symptoms, anxiety, and general health. The trial is not blinded and aims to provide evidence to improve active surveillance protocols while reducing invasive procedures and healthcare costs.
CONDITIONS
Brief Title
Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
Research Team
H
Hashim Ahmed
I
Increase Akinyemi
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Patients with a prostate (cis-male or trans-female with no prior androgen deprivation hormone use)
Diagnostic bi-parametric or multiparametric MRI
Diagnostic systematic biopsy with or without targeted biopsy
Histological diagnosis of localized prostate cancer
Patient has chosen active surveillance
You will not qualify if you...
Active surveillance for more than 9 months before screening
Contraindication to MRI or gadolinium contrast
Previous hip replacement in both hips
Contraindication to biopsy guided by transrectal ultrasound probe
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Active Surveillance with Standard Care
Duration - Up to 5 years
Participants undergo active surveillance according to current NICE guidelines, including PSA blood tests every 3 months in year 1 and every 6 months thereafter, annual rectal examinations if clinically indicated, an MRI at 12 months if not done at diagnosis, and biopsies if changes are detected.
PSA tests every 3 months in year 1, then every 6 months; annual rectal exams if indicated; 1 MRI scan at 12 months if needed; biopsies as clinically indicated
Active Surveillance with Regular MRI Scans
Duration - Up to 5 years
Participants undergo active surveillance with regular MRI scans and PSA tests. Those with visible lesions or medium risk cancer have PSA tests every 6 months and annual MRI scans; others have PSA every 6 months and MRI scans in years 1, 3, and 5. Targeted biopsies are performed if MRI findings indicate progression.
PSA tests every 6 months; MRI scans annually or at years 1, 3, and 5 depending on risk; targeted biopsies if MRI indicates progression
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
The Imperial Prostate 9 - Approaches To Long-term Active Surveillance: Regular MRI scans versus standard of care (IP9-ATLAS) randomised controlled trial.
Archana Gopalakrishnan, Alexander Light, Nikhil Mayor...