title: The Study of Active Monitoring in Sweden (SAMS): a randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer.
abstract: OBJECTIVE
  Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods.
  
  
  METHODS
  SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10-15 years.
  
  
  RESULTS
  Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres.
  
  
  CONCLUSIONS
  It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule.
authors.affiliation: Department of Urology, Helsingborg Hospital, Lund University , Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Bratt
authors.forename: Stefan
authors.initials: S
authors.lastname: Carlsson
authors.forename: Erik
authors.initials: E
authors.lastname: Holmberg
authors.forename: Lars
authors.initials: L
authors.lastname: Holmberg
authors.forename: Eva
authors.initials: E
authors.lastname: Johansson
authors.forename: Andreas
authors.initials: A
authors.lastname: Josefsson
authors.forename: Annika
authors.initials: A
authors.lastname: Nilsson
authors.forename: Maria
authors.initials: M
authors.lastname: Nyberg
authors.forename: David
authors.initials: D
authors.lastname: Robinsson
authors.forename: Jonas
authors.initials: J
authors.lastname: Sandberg
authors.forename: Dag
authors.initials: D
authors.lastname: Sandblom
authors.forename: Pär
authors.initials: P
authors.lastname: Stattin
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D019468:Disease Management; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality / Q000473:pathology*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013548:Sweden / Q000453:epidemiology; D013997:Time Factors; D057832:Watchful Waiting / Q000379:methods*