A Randomised Clinical Trial Comparing Two Biopsy Templates and Follow-up Schedules for Men on Active Surveillance for Low-risk Prostate Cancer: SAMS.

ABSTRACT:

Background and objective

Neither the number nor location of biopsy cores or follow-up schedules for active surveillance of prostate cancer are based on evidence from randomised trials. We therefore initiated a study that compared two follow-up schedules in this setting. The main endpoint was decision to initiate curative treatment within 5 yr from randomisation.

Methods

Men aged 40-75 yr with low-risk prostate cancer (grade group 1, T1c/T2a, ≤33% positive biopsy cores, prostate-specific antigen [PSA] ≤13 μg/l, PSA density ≤0.2 μg/l/cm³) diagnosed with the previous 6 mo were randomly allocated to a standard confirmatory systematic biopsy and standard follow-up, or an extended confirmatory systematic biopsy and less intense follow-up.

Key findings and limitations

SUBMITTER: Robinson D 

PROVIDER: S-EPMC12670916 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature