A Registry in the European Union of Provenge Therapy in Men with Metastatic Castrate-Resistant Prostate Cancer (START)

Study identification

• EU PAS number:
  EUPAS8254
• Study ID:
  9783
• Official title and acronym:
  A Registry in the European Union of Provenge Therapy in Men with Metastatic Castrate-Resistant Prostate Cancer (START)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Netherlands

  United Kingdom
• Study description:
  STUDY WITHDRAWN (Notification 13 May 2015). This is a multicenter, non-interventional registry designed to evaluate the risk of ischemic stroke or MI in subjects with mCRPC who receive commercial Provenge in the EU.
• Study status:
  Planned

Research institutions and networks

Institutions

Department for Urology, University Hospital RWTH Aachen

Charité-Universitätsmedizin

University Medical Centre Hamburg-Eppendorf

Germany

Medical Department, Division of Hematology, Oncology and Tumor Immunology, Charité University Medicine Berlin Augustenburger Platz,1 13353 Berlin, Germany, Martini-Clinic on the grounds of the University Clinic Hamburg-Eppendorf Martinistrasse 52, 20246 Hamburg, Germany, University Clinic Frankfurt, Department for Urology and Pediatric Urology Theodor-Stern-Kai 7, 60590 Frankfurt/M. Germany

Study timelines

Date when funding contract was signed

Planned:01/03/2014

Study start date

Planned:06/03/2014

Data analysis start date

Planned:30/06/2018

Date of interim report, if expected

Planned:08/07/2015

Date of final study report

Planned:31/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Dendreon Corporation

Regulatory

• Was the study required by a regulatory body?:
  Yes