Karim Fizazi1, Per-Anders Abrahamsson2, Goran Ahlgren2, Joaquim Bellmunt3, Daniel Castellano4, Stephane Culine5, Ronald de Wit6, Silke Gillessen7, Juergen E Gschwend8, Freddie Hamdy9, Nicholas James10, Raymond McDermott11, Kurt Miller12, Thomas Wiegel13, Manfred Wirth14, Bertrand Tombal15. 1. Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr. 2. Department of Urology, Lund University, Lund, Sweden, and Malmö University, Malmö, Sweden. 3. Department of Medical Oncology, University Hospital del Mar, UPF University, Barcelona, Spain. 4. Department of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain. 5. Department of Medical Oncology, Hôpital Saint Louis, Paris, France. 6. Department of Medical Oncology, Erasmus Medical Centre Cancer Institute, Rotterdam, The Netherlands. 7. Department of Medical Oncology, Kantonsspital, St. Gallen, Switzerland. 8. Urologische Klinik und Poliklinik der Technischen Universität, München, Germany. 9. Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK. 10. Cancer Research Unit, University of Warwick, Coventry, UK. 11. Department of Medical Oncology, The Adelaide and Meath Hospital, Dublin, Ireland. 12. Klinik für Urologie, Charité-Universitätsmedizin Berlin, Berlin, Germany. 13. Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany. 14. Department of Urology, University Clinic Carl Gustav Carus, Dresden, Germany. 15. Service d'Urologie, Institut de Recherche Clinique, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.
Abstract
CONTEXT: 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. EVIDENCE ACQUISITION: 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. EVIDENCE SYNTHESIS: 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. PATIENT SUMMARY: The Prostate Cancer Consortium in Europe was established to conduct comparative trials aiming at assessing new treatments for prostate cancer patients.
CONTEXT: 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. EVIDENCE ACQUISITION: 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. EVIDENCE SYNTHESIS: 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. PATIENT SUMMARY: The Prostate Cancer Consortium in Europe was established to conduct comparative trials aiming at assessing new treatments for prostate cancer patients.
Authors: Anna Patrikidou; Pierre Maroun; Jean-Jacques Patard; Hervé Baumert; Laurence Albiges; Christophe Massard; Yohann Loriot; Bernard Escudier; Mario Di Palma; Julia Arfi-Rouche; Laurence Rocher; Zahira Merabet; Alberto Bossi; Karim Fizazi; Pierre Blanchard Journal: Clin Transl Radiat Oncol Date: 2018-07-06
Authors: Christopher C Parker; Nicholas D James; Christopher D Brawley; Noel W Clarke; Alex P Hoyle; Adnan Ali; Alastair W S Ritchie; Gerhardt Attard; Simon Chowdhury; William Cross; David P Dearnaley; Silke Gillessen; Clare Gilson; Robert J Jones; Ruth E Langley; Zafar I Malik; Malcolm D Mason; David Matheson; Robin Millman; J Martin Russell; George N Thalmann; Claire L Amos; Roberto Alonzi; Amit Bahl; Alison Birtle; Omar Din; Hassan Douis; Chinnamani Eswar; Joanna Gale; Melissa R Gannon; Sai Jonnada; Sara Khaksar; Jason F Lester; Joe M O'Sullivan; Omi A Parikh; Ian D Pedley; Delia M Pudney; Denise J Sheehan; Narayanan Nair Srihari; Anna T H Tran; Mahesh K B Parmar; Matthew R Sydes Journal: Lancet Date: 2018-10-21 Impact factor: 79.321