Contact information
Type
Scientific
Contact name
Mrs M. Roobol
ORCID ID
Contact details
Erasmus Medical Center
Department of Urology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4634548
m.roobol@erasmusmc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR156
Study information
Scientific title
European Randomised study of Screening for Prostate Cancer
Acronym
ERSPC
Study hypothesis
Screening causes a difference in prostate cancer mortality of 20% or more.
Ethics approval(s)
Local medical ethics committee gave approval
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
Prostate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3.
Intervention type
Other
Primary outcome measure
Prostate cancer mortality compared between the screened and the non-screened group of men at risk.
Secondary outcome measures
1. 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 date
01/10/1991
Overall study end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Males aged 55 - 74 years (including age 74)
Participant type(s)
Patient
Age group
Senior
Sex
Male
Target number of participants
251133
Participant exclusion criteria
Previous diagnosis of prostate cancer
Recruitment start date
01/10/1991
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Belgium, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |