Dr. Molewaterplein 40
3015 GD Rotterdam
Department of Urology
Chris Bangma MD
ERSPC board, Professor and Chairman,
Department of Urology,
Erasmus MC (Erasmus University & Academic Hospital Rotterdam),
Rotterdam, The Netherlands
Monique J Roobol
PO Box 2040
3000 CA Rotterdam
Data on the Dutch arm of the study
The Scientific Committee of ERSPC determined that within the European protocol males aging 55-70 (including age 70) would be recruited. However it was left to the individual national study groups to recruit different age groups.
Within the European protocol only males aged 55-70 years at the time of entry into the randomized study could be included – and they could not have undergone PSA screening beforehand.
The Netherlands’ contribution to ERSPC consists of 42,000 men, aged 55-74 years.
Between October 1991 and December 2000, 42.000 men responded positively to a letter of invitation to enter the ERSPC. The only exclusion criterion was a previous diagnosis of prostate cancer. Written informed consent was obtained from all study subjects. Each participant filled out an AUA7 symptom score form and a baseline-questionnaire concerning their medical history. Those who responded were randomized to either the screening or the control arm.
After five executive pilot studies, the following protocol was used (June 1994-November 1997).
- Men randomized to the screening arm underwent three screening tests:
- Digital Rectal Examination (DRE)
- Transrectal Ultrasonography (TRUS)
- Serum Prostate Specific Antigen (PSA) determination.
- A cut-off value of 4 ng/nl was used as a biopsy indication. Suspicious findings by any of the three diagnostic procedures prompted a sextant prostate biopsy.
- After the evaluation of DRE and TRUS as predictors for biopsy outcome it was decided to change the screening algorithm. From November 1997 until now the protocol was simplified and is only based on serum PSA level.
- A cut-off value of 3 ng/nl was then used as a biopsy indication. Men were then invited for their second screening visit, with an interval of four years.