A Randomised Controlled Trial Comparing Regular MRI Scans to Standard Care in Active Surveillance for Prostate Cancer

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.

Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)