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

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: For men with low-risk prostate cancer, a standard confirmatory biopsy and standard surveillance resulted in a slightly higher 1-yr treatment rate but a similar 5-yr treatment rate to the rates for men who underwent an extended confirmatory systematic biopsy and surveillance without further scheduled biopsies. 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. 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/cm 3 ) 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. Data for 328 men were available for analysis. After 5 yr, 42% in the standard arm and 36% in the experimental arm received treatment with curative intent ( p = 0.51). In first year, more men in the experimental arm were treated, but after 4 yr the treatment rate in the standard arm surpassed that in the experimental arm. Compliance with scheduled biopsies decreased over time. The trial started when magnetic resonance imaging (MRI) was not used for active surveillance in Sweden. Inclusion was stopped before the target of 500 men was reached. Use of an extended confirmatory biopsy may allow for less intensive surveillance of low-risk prostate cancer in a setting without routine use of MRI. This approach has the potential to reduce the burden of repeat biopsies without compromising the effectiveness of disease monitoring. For men with low-risk prostate cancer, use of a more extensive initial biopsy followed by less intensive monitoring resulted in similar 5-year treatment rates as for standard monitoring. This suggests that follow-up with fewer scheduled biopsies can be considered without affecting the overall quality of surveillance when MRI (magnetic resonance imaging) is not available.

Source: European Urology Open Science

DOI: 10.1016/j.euros.2025.10.024

Authors: David Robinson, Jovana Maljkovic, Anna Genell, Stefan Carlsson, Erik Holmberg, Ola Bratt