European Randomised study of Screening for Prostate Cancer

ISRCTN ISRCTN49127736
DOI https://doi.org/10.1186/ISRCTN49127736
Secondary identifying numbers NTR156
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
12/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mrs M. Roobol
Scientific

Erasmus Medical Center
Department of Urology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 4634548
Email m.roobol@erasmusmc.nl

Study information

Study designMulticentre randomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEuropean Randomised study of Screening for Prostate Cancer
Study acronymERSPC
Study objectivesScreening causes a difference in prostate cancer mortality of 20% or more.
Ethics approval(s)Local medical ethics committee gave approval
Health condition(s) or problem(s) studiedProstate cancer
InterventionProstate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3.
Intervention typeOther
Primary outcome measureProstate cancer mortality compared between the screened and the non-screened group of men at risk.
Secondary outcome measures1. Progression-free (tumour free) survival
2. Survival free of metastatic disease
3. Quality of life in the screened and non-screened populations
Overall study start date01/10/1991
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupSenior
SexMale
Target number of participants251133
Key inclusion criteriaMales aged 55 - 74 years (including age 74)
Key exclusion criteriaPrevious diagnosis of prostate cancer
Date of first enrolment01/10/1991
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Belgium
  • Finland
  • France
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland

Study participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6)

No information available

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/03/2009 Yes No
Results article results 01/08/2011 Yes No
Other publications 11-year follow-up 15/03/2012 Yes No
Results article results 01/05/2012 Yes No
Results article results 01/11/2012 Yes No
Results article results 01/02/2014 Yes No
Other publications 13-year follow-up 06/12/2014 Yes No
Results article results 01/08/2015 Yes No

Editorial Notes

12/04/2016: Publication reference added.