Within the ERSPC-study, several committees have been installed for the surveillance of quality and progess of the trial. The following committees will be active in the surveillance of the project’s quality and progress:
Scientific Committee^
The Scientific Committee (SC) consists of two persons per participating center and is chaired by Prof. dr. Monique J. Roobol, Epidemiologist and Professor in Urological Decision Making in Rotterdam (NL). Twice a year there will be a meeting with all the members of the Scientific Committee. At these meetings each participating center will give an update of their data.
Members of the Scientific Committee
- Prof.dr. Anssi Auvinen
Unit of Health Sciences
Faculty of Social Sciences
Tampere University
FIN-33014 Tampere
Finland
E-mail: anssi.auvinen@tuni.fi - Prof.Dr. Teuvo Tammela
Professor and Chief of Urology
Department of Urology
Tampere University Hospital and Faculty of Medicine and Health Technology
Tampere University
FIN-33014 Tampere
Finland
E-mail: teuvo.tammela@tuni.fi - Prof.Dr. Arnauld Villers
Service d’Urologie
Hopital Huriez
Centre hospitalier regional universitaire Lille II
59037 Lille
France
Fax: +33 3 2044 6915
E-mail: arnauld.villers@wanadoo.fr - Dr. Xavier Rebillard
Service d’urologie
Clinique Beau Soleil
119, Avenue Lodeve
34000 Montpellier
France
Fax: 33 467 759765
e-mail: xavier.rebillard@wanadoo.fr - Dr. Vera Nelen
Provinciaal Instituut voor Hygiene
Kronenburgstraat 45
B-2000 ANTWERPEN 1
Belgium
E-mail: Vera.Nelen@provincieantwerpen.be - Dr. Liesbet van Eycken
Director, Belgian Cancer Registry
Brussels
Belgium
E-mail: elizabeth.vaneycken@kankerregister.org - Prof. Dr. Chris H. Bangma
Erasmus University Medical Center Rotterdam
Dept. of Urology
PO BOx 2040
3000 CA ROTTERDAM
The Netherlands
E-mail: c.h.bangma@erasmusmc.nl - Prof.Dr. Monique J. Roobol
International Coordinator
Erasmus University Medical Center Rotterdam
Dept. of Urology
P.O. Box 2040
3000 CA ROTTERDAM
The Netherlands
E-mail: m.roobol@erasmusmc.nl - Dr. Donella Puliti
ISPRO
Oncological network, Prevention, and Research Institute
Firenze
Italy
E-mail: d.puliti@ispro.toscana.it - Dr. Giuseppe Gorini
ISPRO
Oncological network, Prevention, and Research Institute
Firenze
Italy
E-mail: g.gorini@ispro.toscana.it - Prof.dr. Jonas Hugosson
Dept. of Urology
Institute of Clinical Sciences
Sahlgrenska Academy at the University of Göteborg
Göteborg
Sweden
E-mail: jonas.hugosson@gu.se - Dr. Rebecka Arnsrud-Godtman
Dept. of Urology
Institute of Clinical Sciences
Sahlgrenska Academy at the University of Göteborg
Göteborg
Sweden
E-mail: r.godtman@gmail.com - Dr. Alvaro Paez
Dept. of Urology
Hospital Universitario de Fuenlabrada
Madrid
Spain
E-mail: alvaro.paez@salud.madrid.org - Dr. Marcos Luján
Dept. of Urology
Hospital Infanta Cristina
Parla, Madrid
Spain
E-mail: mlujan@salud.madrid.org - Dr.med. Maciej Kwiatkowski
Dept. of Urology
Cantonal Hospital Aarau
CH-5001 Aarau
Switzerland
E-mail: maciej.kwiatkowski@ksa.ch - Prof.Dr.med. Stephen Wyler
Dept. of Urology
Cantonal Hospital Aarau
CH-5001 Aarau
Switzerland
E-mail: stephen.wyler@ksa.ch
Data Monitoring Committee^
The Data Monitoring Committee (DMC) has regular 2-yearly meetings and is chaired by Dr. Phillip Smith, Urologist in Leeds (GB).
General tasks of the committee:
The DMC will monitor the work and protocols of all participating study centers as well as the work of the other committees active in the study.
Information to the DMC will be provided in two ways, as ‘raw data’ annually and as ‘filtered data’ (information that has passed certain committees) for review.
The DMC has the power to review interim data and to determine whether the study (centre) needs change, discontinuation or to proceed, and to monitor all ethical aspects of the study. It has established flagging rules to do both. The secretary will coordinate information exchange between the study centers and the DMC.
Furthermore the DMC has composed the following tables which are to be completed annually by each study centre.
- Table 1: Recruitment
- Table 1B: Age distribution of men
- Table 2: Uptake of screening
- Table 3A: Assessment, biopsy, and cancer detection rates (1st screen)
- Table 3B: Assessment, biopsy, and cancer detection rates (routine screen)
- Table 4A: Clinical stage distribution of prostate cancers
- Table 4B: Pathology stage distribution of prostate cancers
- Table 4C: Gleason score distribution of prostate cancers
- Table 5: Treatment by stage
- Table 6: All-cause mortality rates
- Table 7: Prostate cancer incidence rates
- Table 8: Prostate cancer mortality rates
Members
- Mr. Philip Smith
Consultant urologist
2 Creskeld Lane
Bramhope
Leeds, West Yorkshire LS16 9AW
United Kingdom
Fax: +44 113 285 7247
E-mail: philip.smith53@btinternet.com - Timo Hakulinen, D.Soc.Sc.
Finnish Cancer Registry
Liisankatu 21b
FIN-00170 Helsinki
Finland
Fax: + 358-1-135 5378
E-mail: timo.hakulinen@cancer.fi - Dr. H.J. de Koning
Dept. of Public Health
Erasmus University Rotterdam
P.O. Box 1738
3000 DR ROTTERDAM
The Netherlands
Fax:+31.10.408.94.49
E-mail: h.dekoning@erasmusmc.nl - Dr. S. Moss
Associate Director
Cancer Screening Evaluation Unit
SRD, Institute of Cancer Research
Cotswold Road
Sutton, Surrey, SM25NG
United Kingdom
e-mail: sue.moss@icr.ac.uk - J. Adolfsson, MD
Director Oncologic center, M8
Karolonska Hospital
17176 Stockholm
Sweden
Fax: + 46 8 348640
E-mail: jan.adolfsson@smd.sll.se
Causes of Death Committee^
The local Causes of Death Committees (CoD) focus on the following question:
‘Would this man have died at this moment if prostate cancer had not been present?’
Therefore, all deaths among patients who are diagnosed with prostate cancer within the study population are considered deaths due to prostate cancer unless another cause of death can be proven. This includes patients who have died as a result of the screening procedure, biopsy procedure, and/or treatment.
Each case will be discussed by the members of the committee. The cases will be presented to the committee anonymously, and blinded towards screening or control group. Evaluation of each case is done by means of completion of two standardized forms.
In some centers no local Cause of Death Committee is in work anymore. Instead cause of death coding is based on the official cause of death certificates.
Belgium
Currently, cause of death coding is based on official cause of death certificates (immediate, underlying, or complementary is retrieved). Previous members of the committee were: Vera Nelen, Louis Denis, Annemie Hermans, and Guy Thys.
Finland
Currently, cause of death coding is based on official cause of death certificates. No Cause of Death Committee in work.
Previous members of the committee were: Pekka J. Karhunen, Tuukka Mäkinen, Jorma Lahtela, Jussi Aro (deceased).
France
Cause of death coding is based on certificates. A comparison with a random sample of reviewed causes of death showed no differences.
Italy
Currently, cause of death coding is based on official cause of death certificates. No Cause of Death Committee in work.
The Netherlands
Active local Cause of Death Committee. Members are: Wim Kirkels, MD, PhD, urologist, Arjen Noordzij, MD, PhD, urologist, Tycho Lock, MD, urologist, Prof. Chris Bangma, MD, PhD, urologist.
Spain
Active local Cause of Death Committee. Members are: Alvaro Paez, Marcos Lujan.
Sweden
Active local Cause of Death Committee. Members are: Per Folmertz, Eberhard Varenhorst, Silas Pettersson.
Switzerland
Active local Cause of Death Committee. Members are: Prof.dr. Stephen Wyler, urologist (chairman), Prof.dr. Johann Steurer, Internist, Prof.dr. Peter Hammerer, Urologist, Prof.dr. Michael Kurrer, Pathologist (on ad hoc basis).
Quality Control Committee^
The QCC meets on a 6-months regular basis or exceptionally on member request.
The QCC has been appointed by the ERSPC to:
- verify that active centers fulfil to the admission criteria of ERSPC, by means of a questionnaire/checklist (see addendum 25) and of site visits, if needed.
- verify that active centers have available (and agree to provide) a minimal data set to the centralized DMC, by means of questionnaire/checklist (see addendum 26), and of site visits if needed.
- verify the compliance to the ERSPC protocol and the internal consistency of data according to a periodic check, based on the data set provided every year by active centers. Performance indicators will be provided to the QCC by DMC.
- report to the SC the results of checks 1 and 2, suggesting that single centers are eligible to participate to ERSPC. Report to the SC any result from check 3, which suggests major deviations from protocol or data inconsistency, apparently not compatible with ERSPC requirements.
Members
- Dr. H.J. de Koning
Dept. of Public Health
Erasmus University Rotterdam
P.O. Box 1738
3000 DR ROTTERDAM
The Netherlands
Fax:+31.10.408.94.49
E-mail: h.dekoning@erasmusmc.nl - Prof. A. Auvinen
Tampere School of Public Health
University of Tampere
FIN-33014 Tampere
Finland
Fax:+358 3 2156 057
E-mail: anssi.auvinen@uta.fi - Mrs. dr. V. Nelen
Provinciaal Instituut voor Hygiene
Kronenburgstraat 45
B-2000 ANTWERPEN 1
Belgium
Fax:+32.3.25.91.201
E-mail: epidemiologie@pih.provant.be - Dr. J. Hugosson
Dept. of Urology
Sahlgrenska University Hospital
S-413 45 GOTEBORG
Sweden
Fax: +46 31 419648
E-mail: jonas.hugosson@urology.gu.se
International Epidemiology Committee^
The Epidemiology Committee (EC) is chaired by Dr. Freda Alexander, Epidemiologist in Edinburgh (GB). The tasks of the EC are:
- To monitor the conduct of the study, adherence to trial design insofar as these are relevant to final co-ordinated analyses, which are;
- the analysis of prostate cancer mortality and the interpretation of these results
- analyses of sensitivity, sojourn time and survival leading to recommendations regarding choice of modalities for screening, frequency of screening and interim end-points for use in the future.
- To be responsible on behalf of the SC for the administration of the centralised data-base. This authority will be exercised primarily by the chairperson of the epidemiology committee. Each center will supply data at six-monthly intervals.
- To report to the SC of ERSPC to advise it on all matters relevant to the centralised statistical analysis and the appropriate use, protection and ownership of data held on behalf of the SC at the data centre. This must satisfy the dataprotection regulations of each country. Reports to be provided six-monthly.
- To produce and evaluate routine reports on the centralised data. These will be presented to the SC of ERSPC, local trialists and other relevant sub-committees. The chairperson, on behalf of the committee, shall be responsible for the validity of those reports.
- To scrutinise all trial protocols with respect to epidemiology aspects. To consider all protocols for ‘grafted’ studies (i.e., epidemiological and other studies which are independent but use the facilities affunded by trial framework).
- To liaise in all these activities with the quality control committee and the data monitoring committee.
Members
- Dr. S. Moss
Associate Director Cancer Screening Evaluation Unit
SRD, Institute of Cancer Research
Cotswold Road
Sutton, Surrey, SM25NG
United Kingdom
e-mail: sue.moss@icr.ac.uk - Prof. Matti Hakama
Tampere School of Public Health
University of Tampere
FIN-33014 Tampere
Finland
Fax +358-3-215 6057
E-mail: matti.hakama@cancer.fi - Prof. A. Auvinen
Tampere School of Public Health
University of Tampere
FIN-33014 Tampere
Finland
Fax:+358 3 2156 057
E-mail: anssi.auvinen@uta.fi - Vincent Bataille
ADIMEP Administrative Center
66, Chemin du Vallon
BP 4420
31405 Toulouse Cedex 4
France
E-mail: vincent.bataille@caramail.com - Dr. Pascale Grosclaude
Directrice scientifique
Epidemiologist
Registre des Cancers du Tarn
Chemin des trois Tarn
81000 ALBI
France
Fax : +33 5 62 26 42 60
E-mail: grosclau@cict.fr - Mrs. dr. V. Nelen
Provinciaal Instituut voor Hygiene
Kronenburgstraat 45
B-2000 ANTWERPEN 1
Belgium
Fax:+32.3.25.91.201
E-mail: epidemiologie@pih.provant.be - Dr. H.J. de Koning
Dept. of Public Health
Erasmus University Rotterdam
P.O. Box 1738
3000 DR ROTTERDAM
The Netherlands
Fax:+31.10.408.94.49
E-mail: h.dekoning@erasmusmc.nl
Advisors
- Drs. R.A.M. Damhuis
Rotterdam Cancer Registry
P.O. Box 289
3000 AG ROTTERDAM
The Netherlands
Fax:+31.10.436.47.84
E-mail: damhuis@ikr.nl - Dr. M. Roobol
Dept. of Urology
Erasmus MC
P.O. Box 2040
3000 CA ROTTERDAM
The Netherlands
F ax:+31.10.463.5315
E-mail: m.roobol@erasmusmc.nl - Prof.Dr. F.H. Schröder
International Coordinator
Dept. of Urology
Erasmus University and Academic
Hospital Rotterdam
P.O. Box 2040
3000 CA ROTTERDAM
The Netherlands
Fax:+31.10.463.58.38
E-mail: secr.schroder@erasmusmc.nl
P.S.A. Committee^
The PSA-standardisation committee is coordinated by Dr. Bert Blijenberg, Clinical Chemist in Rotterdam (NL). The first aim of this committee is the assessment of laboratory performance among all partners in the study.
For 1997 a quality control programme for total prostate-specific antigen (PSA) is proposed. The organisation of this programme is in the hands of the Dutch Quality Assessment Foundation. Six times per year two human serum samples will be sent to all partners. The elaboration of the results will be done statistically as well as graphically by using Youden plots.
In the future other activities will be focused on the standardisation of PSA assays and on the assessment of free and total PSA.
Members
- Dr. B.G. Blijenberg
Dept. of Clinical Chemistry
Erasmus University and
Academic Hospital Rotterdam
P.O. Box 2040
3000 CA ROTTERDAM
The Netherlands
Fax:+31.10.436.78.94
E-mail: b.g.blijenberg@planet.nl - Dr. H. Neels
Dept. of Biochemistry
Academic Hospital Middelheim
Lindendreef 1
2020 ANTWERP
Belgium
Fax:+32.3.218.5026 - Prof H. Lilja
Memorial Sloan-Kettering Cancer Center
1275 York Avenue, Box 27
New York, New York 10021
Phone: +1 212 639 6982
Fax: +1 646 422 2379
USA
E-mail: liljah@mskcc.org - Dr. Gilles Salama
service de biologie
Centre Hospitalier Intercommunal Castres-Mazamet
BP 417 20, Boulevard Marechal Foch
81108 Castres CeDEX
France
E-mail: labo@chic-castres-mazamet.com - Ulf-Håkan Stenman, M.D.
Professor, Dept. of Clinical Chemistry
Helsinki University Central Hospital
Häärtmaninkatu 2
PB 140
FIN-00290 HELSINKI
Finland
Fax:+358.9.471.74804
E-mail: ulf-hakan.stenman@hus.fi
Pathology Committee^
The chairman of the Pathology Committee is Prof. Theo van der Kwast, Pathologist in Toronto (CAN). The Pathology Committee will guard the uniformity in tissue processing and nomenclature of diagnosis and staging terms in the histopathological reporting of sextant needle biopsies, enhance the quality of histopathological diagnosis, and reduce the inter-observer variation particularly in grading and staging of prostatic adenocarcinomas. The Pathology Committee will use the following methods:
- The pathology departments of all participating centers will report on sextant needle biopsies by using exclusively the diagnostic terms as mentioned at the Consensus Workshop on Prostatic Screening held in Antwerp (see Denis L, Murphy GP, Schröder FH. Cancer 1995; 75: 1178-1207). Ambiguous terms like atypia, suspect or “consistent with” may not be used.
- All centers use a standardised reporting form.
- Each center appoints a reference pathologist who is responsible for the completion of the prostatic needle biopsy forms. In addition he/she can be consulted by his/her colleagues.
- The reference pathologist reviews all needle biopsies of patients reported to have lesion of indeterminate malignancy, a precancerous lesion or an overt malignancy.
- The reference pathologist of all centers meet once a year and participate in a slide panel discussion. For this, each reference pathologist submits slides with:
- PC adenocarcinoma Gleason score 2-4 (N=2)
- PC adenocarcinoma Gleason score 5-6 (N=2)
- PC adenocarcinoma Gleason score 7-8 (N=2)
- PC adenocarcinoma Gleason score > 8 if any (N=1)
- dubious malignancy (N=4, if possible)
- low grade Prostatic Intra-epithelial Neoplasia (PIN) (N=2, if possible)
- high grade PIN (N=2, if possible)
- non-adenocarcinomas (if possible)
During the annual conference each slide will be evaluated (blindly) by each pathologist independently and their diagnosis will be compared.
The Pathology Committee consists of all reference pathologists and two or three external expert pathologists. The Committee reports to the Quality Control Committee.
Members
- Prof. Dr. Th.H. van der Kwast
Dept. of Pathology and Laboratory Medicine
Mount Sinai Hospital
600 University Avenue
Toronto
Canada M5G 1X5
E-mail: Theodorus.vanderKwast@uhn.on.ca - Dr. I. Neetens
Dept. of Pathology
Academic Hospital Middelheim
Lindendreef 1
2020 ANTWERP
Belgium
Fax:+32.3.280.4816 - Dr. Gabriella Nesi
Dept. of Pathology
University of Florence
Viale Morgagni, 85
50134 FIRENZE
Italy
Fax:+39.055.437.98.68
E-mail: g_nesi@yahoo.com - Dr. Simonetta Di Lollo
Dept. of Pathology
University of Florence
Viale Morgagni 85
I-50134 Firenze
Italy
Fax: +39 055 437 9868
E-mail: s_dilollo@unifi.it - Dr. C-G. Pihl
Klinik patologi och Cytologi
Gula Straket 8
SU Sahlgrenska
SE-41345 GÖTEBORG
Sweden
Fax:+46.31.823715
E-mail: carl.gustaf.pihl@telia.com - Dr. Carlos Santonja
Hospital Universitario de Getafe
Anatomia Patológica
Carretera de Toledo, Km. 12,5
28905 Getafe, Madrid
Spain
Fax: +34 91 6965306
E-mail: csantonja@hugf.insalud.es - Dr. Paula Martikainen
dept. of Pathology
Tampere University Hospital
P.O. Box 2000
FIN-33521 Tampere
Finland - Dr. Marita Laurila
Central Hospital of Kanta-Häme
Dept. of Pathology
13530 Hämeenlinna
Finland
Fax: + 35 82 6292180
E-mail: marita.laurila@khshp.htk.fi - Dr. Susanne Dragoje
Oberärtzin Pathologie
kantonspital Aarau, Aarau
Switzerland
E-mail: susanne.dragoje@ksa.ch - Dr. Lukas Bubendorf
Institute for Pathology
University of Basel
Schönbeinstrasse 40
CH-4003 Basel
Switzerland
Fax: +41 61 265 3194
E-mail: lbubendo@bluewin.ch - Dr. I. Serre
service d’anetomopatologie
CHU Montpellier
Hospital Lapeyronie
Avenue Doyen Giraud
34000 Montpellier
France
E-mail: i-serre@chu-montpellier.fr - Dr. C. Mazerolles
Dept. of Pathology
pl. Doct. Baylac
31059 Toulouse
France
E-mail: mazerolles.c@chu-toulouse.fr