Achievements and perspectives in prostate cancer phase 3 trials from genitourinary research groups in Europe: introducing the Prostate Cancer Consortium in Europe.

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.

• Authors: Karim Fizazi, Per-Anders Abrahamsson, Goran Ahlgren, Joaquim Bellmunt, Daniel Castellano, Stephane Culine, Ronald de Wit, Silke Gillessen, Juergen E Gschwend, Freddie Hamdy, Nicholas James, Raymond McDermott, Kurt Miller, Thomas Wiegel, Manfred Wirth, Bertrand Tombal
• Journal: European urology (Eur Urol) Vol. 67 Issue 5 Pg. 904-12 (May 2015) ISSN: 1873-7560 [Electronic] Switzerland
• PMID: 25218582 (Publication Type: Journal Article)
• Copyright: Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Topics

• Achievement
• Clinical Trials, Phase III as Topic
• Europe
• Humans
• Male
• Prostatic Neoplasms (therapy)
• Urology (organization & administration, trends)