title: Achievements and perspectives in prostate cancer phase 3 trials from genitourinary research groups in Europe: introducing the Prostate Cancer Consortium in Europe.
abstract: BACKGROUND
  Phase 3 trials have made major contributions to advances in prostate cancer (PCa). However, funding limitations and excess bureaucracy are now making it difficult to conduct trials.
  
  
  OBJECTIVE
  To describe the collaborative groups in Europe and their academic phase 3 PCa trials.
  
  
  METHODS
  Leaders of collaborative groups from Scandinavia, the European Organisation for Research and Treatment of Cancer (EORTC), France, Spain, the United Kingdom, Germany, Switzerland, The Netherlands, and Ireland were asked to provide information.
  
  
  RESULTS
  Approximately 40 academic European phase 3 trials focussing on PCa have been completed, and about 10 are accruing patients. Cross-border trials have been successfully conducted led by EORTC (11), Scandinavian Prostate Cancer Group (9), European Association of Urology (1), Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficiency (STAMPEDE) (1), and the French Genito-Urinary Tumor Group (1). Among these studies were practise-changing trials showing the superiority of prostatectomy over watchful waiting in patients <65 yr of age, the benefits of combining androgen-deprivation therapy (ADT) with radiation therapy (RXT) in high-risk localised disease, the superiority of long-term versus short-term ADT, the benefit of RXT in men treated with ADT, and the role of adjuvant RXT. To bridge the numbers gap for phase 3 studies, the Prostate Cancer Consortium in Europe (PEACE) is a recently established initiative that aims to favour cross-border networks of investigators. PEACE 1 is testing the addition of abiraterone and that of RXT directed at the primary cancer in patients with de novo metastatic PCa treated with ADT. PEACE 2 is testing the addition of cabazitaxel and that of pelvic irradiation in patients with at least two criteria for high-risk localised PCa.
  
  
  CONCLUSIONS
  European academic phase 3 trials have contributed to establishing the current standard treatment of PCa. The PEACE consortium was recently tasked with the goal of addressing unanswered questions and specific biology-related issues more efficiently.
  
  
  RESULTS
  The Prostate Cancer Consortium in Europe was established to conduct comparative trials aiming at assessing new treatments for prostate cancer patients.
authors.affiliation: Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.
authors.forename: Karim
authors.initials: K
authors.lastname: Fizazi
authors.affiliation: Department of Urology, Lund University, Lund, Sweden, and Malmö University, Malmö, Sweden.
authors.forename: Per-Anders
authors.initials: PA
authors.lastname: Abrahamsson
authors.affiliation: Department of Urology, Lund University, Lund, Sweden, and Malmö University, Malmö, Sweden.
authors.forename: Goran
authors.initials: G
authors.lastname: Ahlgren
authors.affiliation: Department of Medical Oncology, University Hospital del Mar, UPF University, Barcelona, Spain.
authors.forename: Joaquim
authors.initials: J
authors.lastname: Bellmunt
authors.affiliation: Department of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Castellano
authors.affiliation: Department of Medical Oncology, Hôpital Saint Louis, Paris, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Culine
authors.affiliation: Department of Medical Oncology, Erasmus Medical Centre Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: de Wit
authors.affiliation: Department of Medical Oncology, Kantonsspital, St. Gallen, Switzerland.
authors.forename: Silke
authors.initials: S
authors.lastname: Gillessen
authors.affiliation: Urologische Klinik und Poliklinik der Technischen Universität, München, Germany.
authors.forename: Juergen E
authors.initials: JE
authors.lastname: Gschwend
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.
authors.forename: Freddie
authors.initials: F
authors.lastname: Hamdy
authors.affiliation: Cancer Research Unit, University of Warwick, Coventry, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: James
authors.affiliation: Department of Medical Oncology, The Adelaide and Meath Hospital, Dublin, Ireland.
authors.forename: Raymond
authors.initials: R
authors.lastname: McDermott
authors.affiliation: Klinik für Urologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Miller
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wiegel
authors.affiliation: Department of Urology, University Clinic Carl Gustav Carus, Dresden, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Wirth
authors.affiliation: Service d'Urologie, Institut de Recherche Clinique, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Tombal
mesh_terms: D000124:Achievement; D017326:Clinical Trials, Phase III as Topic; D005060:Europe; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D014572:Urology / Q000458:organization & administration* / Q000639:trends*
keywords: Clinical research; European consortium; Phase 3 trials