Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
01/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.erspc.org

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

NTR156

Study information

Scientific title

Acronym

ERSPC

Study hypothesis

Screening causes a difference in prostate cancer mortality of 20% or more.

Ethics approval

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

Trial setting

Hospitals

Trial type

Screening

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/1991

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Males aged 55 - 74 years (including age 74)

Participant type

Patient

Age group

Senior

Gender

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

Trial 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

http://www.erasmusmc.nl/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19297566
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21601352
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22264679
2012 11-year follow up in: http://www.ncbi.nlm.nih.gov/pubmed/22417251
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22704366
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23954085

Publication citations

  1. Results

    Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Määttänen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A, , Screening and prostate-cancer mortality in a randomized European study., N. Engl. J. Med., 2009, 360, 13, 1320-1328, doi: 10.1056/NEJMoa0810084.

  2. Results

    Zhu X, van Leeuwen PJ, Bul M, Otto SJ, de Koning HJ, Bangma CH, Schröder FH, Roobol MJ, Disease-specific survival of men with prostate cancer detected during the screening interval: results of the European randomized study of screening for prostate cancer-Rotterdam after 11 years of follow-up., Eur. Urol., 2011, 60, 2, 330-336, doi: 10.1016/j.eururo.2011.05.013.

  3. Results

    Wu GH, Auvinen A, Yen AM, Hakama M, Tammela TL, Stenman UH, Kujala P, Ruutu M, Chen HH, The impact of interscreening interval and age on prostate cancer screening with prostate-specific antigen., Eur. Urol., 2012, 61, 5, 1011-1018, doi: 10.1016/j.eururo.2012.01.008.

  4. Results

    Schröder FH, Hugosson J, Carlsson S, Tammela T, Määttänen L, Auvinen A, Kwiatkowski M, Recker F, Roobol MJ, Screening for prostate cancer decreases the risk of developing metastatic disease: findings from the European Randomized Study of Screening for Prostate Cancer (ERSPC)., Eur. Urol., 2012, 62, 5, 745-752, doi: 10.1016/j.eururo.2012.05.068.

  5. Results

    Bokhorst LP, Bangma CH, van Leenders GJ, Lous JJ, Moss SM, Schröder FH, Roobol MJ, Prostate-specific antigen-based prostate cancer screening: reduction of prostate cancer mortality after correction for nonattendance and contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer., Eur. Urol., 2014, 65, 2, 329-336, doi: 10.1016/j.eururo.2013.08.005.

  6. Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Páez A, Määttänen L, Bangma CH, Aus G, Carlsson S, Villers A, Rebillard X, van der Kwast T, Kujala PM, Blijenberg BG, Stenman UH, Huber A, Taari K, Hakama M, Moss SM, de Koning HJ, Auvinen A, , Prostate-cancer mortality at 11 years of follow-up., N. Engl. J. Med., 2012, 366, 11, 981-990, doi: 10.1056/NEJMoa1113135.

Additional files

Editorial Notes