title: Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial.
abstract: BACKGROUND
  Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The 'Football Club (FC) Prostate' study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer.
  
  
  METHODS
  Using a single-center randomized controlled design, 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6 months or more at The Copenhagen University Hospital will be enrolled on this trial. After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care. The soccer intervention will consist of 12 weeks of training 2-3 times/week for 45-60 min after which the assessment protocol will be repeated. Soccer training will then continue bi-weekly for an additional 20 weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects. The primary endpoint is changes in lean body mass from baseline to 12 weeks assessed by dual X-ray absorptiometry scan. Secondary endpoints include changes of cardiovascular, metabolic, and physical function parameters, as well as markers of bone metabolism and patient-reported outcomes.
  
  
  CONCLUSIONS
  The FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT. The results may pave the way for innovative, community-based interventions in the approach to treating prostate cancer.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01711892.
authors: Jacob
authors: J
authors: Uth
authors: Jakob Friis
authors: JF
authors: Schmidt
authors: Jesper Frank
authors: JF
authors: Christensen
authors: Therese
authors: T
authors: Hornstrup
authors: Lars Juel
authors: LJ
authors: Andersen
authors: Peter Riis
authors: PR
authors: Hansen
authors: Karl Bang
authors: KB
authors: Christensen
authors: Lars Louis
authors: LL
authors: Andersen
authors: Eva Wulff
authors: EW
authors: Helge
authors: Klaus
authors: K
authors: Brasso
authors: Mikael
authors: M
authors: Rørth
authors: Peter
authors: P
authors: Krustrup
authors: The University Hospitals Centre for Health Care Research (UCSF), Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark. julie@ucsf.dk.
authors: Julie
authors: J
authors: Midtgaard
mesh_terms: D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001835:Body Weight; D005081:Exercise Therapy; D006801:Humans; D008297:Male; D053580:Muscle Strength; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D057173:Recreation Therapy; D012107:Research Design; D057566:Self Report; D012916:Soccer; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal