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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.

Bratt, Ola LU ; Carlsson, Stefan ; Holmberg, Erik ; Holmberg, Lars ; Johansson, Eva ; Josefsson, Andreas ; Nilsson, Annika ; Nyberg, Maria ; Robinsson, David and Sandberg, Jonas , et al. (2013) In Scandinavian Journal of Urology 47(5). p.347-355
Abstract
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. Material and 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... (More)
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. Material and 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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Scandinavian Journal of Urology
volume
47
issue
5
pages
347 - 355
publisher
Taylor & Francis
external identifiers
  • wos:000325524600001
  • pmid:23883427
  • scopus:84885393349
  • pmid:23883427
ISSN
2168-1813
DOI
10.3109/21681805.2013.813962
language
English
LU publication?
yes
id
d3b9c435-6ea2-4d3c-b812-0ea2d6d51ade (old id 3955608)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/23883427?dopt=Abstract
date added to LUP
2016-04-01 10:54:24
date last changed
2022-04-12 18:41:06
@article{d3b9c435-6ea2-4d3c-b812-0ea2d6d51ade,
  abstract     = {{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. Material and 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.}},
  author       = {{Bratt, Ola and Carlsson, Stefan and Holmberg, Erik and Holmberg, Lars and Johansson, Eva and Josefsson, Andreas and Nilsson, Annika and Nyberg, Maria and Robinsson, David and Sandberg, Jonas and Sandblom, Dag and Stattin, Pär}},
  issn         = {{2168-1813}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{347--355}},
  publisher    = {{Taylor & Francis}},
  series       = {{Scandinavian Journal of Urology}},
  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.}},
  url          = {{http://dx.doi.org/10.3109/21681805.2013.813962}},
  doi          = {{10.3109/21681805.2013.813962}},
  volume       = {{47}},
  year         = {{2013}},
}