Committee Structure

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 two persons per participating center and is chaired by Prof. dr. Fritz H. Schröder, Urologist 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. 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
  • Prof. Dr. Teuvo Tammela
    Professor and Chief of Urology
    Division of Urology
    Tampere University Hospital
    P.O. Box 2000
    FIN-33521 TAMPERE
    Finland
    Fax:+358.3.247.4371
    E-mail: teuvo.tammela@uta.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
  • 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
  • Prof. Dr. L. Denis
    Director, Oncology Centre Antwerp
    Lange Gasthuisstraat 35-37
    2000 ANTWERP
    Belgium
    Fax: +32.3.223.53.52
    E-mail: louis.denis@skynet.be
  • Prof. Dr. Ch. H. Bangma
    Urologist
    Erasmus Medical Centre
    Dept. of Urology
    Dr. Molewaterplein 40
    3015 GD ROTTERDAM
    The Netherlands
    Tel: +31 10 463 3607
    Fax: +31 10 463 3858
    E-mail: h.j.vanalphen@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
  • Dr. M. Zappa
    Unit of Epidemiology
    C.S.P.O
    Via di San Salvi 12
    50135 Firenze
    Italy
    Fax: +39 055 679954
    E-mail: m.zappa@ispo.toscana.it
  • Prof. J. Hugosson
    Dept. of Urology
    University of Gothenburg
    S-413 45 GOTEBORG
    Sweden
    Tel: +46 31 342 39 05
    Fax: +46 31 41 62 95
    E-mail: jonas.hugosson@urology.gu.se
  • Dr. S. Carlsson
    Dept. of Urology
    University of Gothenburg
    S-413 45 GOTEBORG
    Sweden
    Tel: +46 31 342 39 05
    Fax: +46 31 41 62 95
  • Dr. A. Berenguer Sanchez
    Hospital Universitario de Getafe
    Carretera Madrid-Toledo, km 12,5
    S-28905 GETAFE (Madrid)
    Spain
    Tel: +34.91.683.3271/+34 91 683 9360
    Fax:+34.91.683.3271
    E-mail: uroget@yahoo.es
  • Dr. M. Luján
    Dept. of Urology
    Hospital Universitario de Getafe
    Ctra. Toledo km 12,500
    28905 Getafe (Madrid)
    Spain
    Fax:+34.91.683.3271
    E-mail: marcoslujan@terra.es
  • Dr. M. Kwiatkowski
    Urologische Klinik
    Kantonsspital Aarau AG
    CH-5001 Aarau
    Switzerland
    Tel: +41.62.838.4747
    Fax: +41.62.838.4753
    E-mail: maciej.kwiatkowski@ksa.ch
  • Prof. Dr. F. Recker
    Urologische Klinik
    Kantonsspital Aarau AG
    Tellstrasse
    CH-5001 AARAU
    Switzerland
    Tel: +41.62.838.4737
    Fax: +41.62.838.4753
    E-mail: franz.recker@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 Causes of Death Committee (CoD) functions at each study center and focus on the following question:
‘Would this man have died at this moment if prostate cancer had not been present?’

Therefore, all death among patients who are diagnosed with PC 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 treatment.
Each case will be discussed by the members of the committee who are not involved in the study. 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 standardised forms.

Members

  • Dr. H.J. de Koning
    Dept. of Public Health
    Erasmus MC
    P.O. Box 1738
    3000 DR ROTTERDAM
    The Netherlands
    Fax:+31.10.408.94.49
    E-mail: h.dekoning@erasmusmc.nl
  • Dr. J. W. Merckelbach
    Straatweg 145
    3054 AC Rotterdam
    The Netherlands
    E-mail: j.merkelbach@net.hcc.nl
  • Dr. W.J. Hoekstra
    Chair NL COD committee
    Zandstraat 2
    5242 GR Rosmalen
    The Netherlands
    E-mail: red.mermaid@12move.nl
  • 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. P. van Vliet
    ACZA Campus St. Elisabeth
    Dienst Urologie
    Leopoldstraat 26
    B-2000 ANTWERP
    Belgium
    Fax:+32.3.223.53.52
  • Dr. H. Verhaegen
    Oncology Centre Antwerp
    Apt. 2, Blok H
    Lange Gasthuisstraat 35-37
    B-2000 Antwerp
    Belgium
    Fax: +32 3223 5352
    E-mail: verhaegen.herman@skynet.be
  • Dr. A. Hermans
    Oncology Centre Antwerp
    Apt. 2, Blok H
    Lange Gasthuisstraat 35-37
    B-2000 Antwerp
    Belgium
    Fax: +32 3223 5352
    E-mail: annemie.hermans@ocmw.antwerpen.be
  • Prof. Pekka J. Karhunen
    Department of Forensic Medicine
    School of Medicine, B-Building
    Tampere University
    FIN-33014 Tampere
    Finland
    Fax: +358 3 2157511
    E-mail: pekka.karhunen@uta.fi
  • Dr. Jussi Aro
    Maria Hospital
    Lapinlahdenkatu 16
    FIN – 00180 Helsinki
    Finland
    E-mail: jussi.aro@hus.fi
  • Dr. Tuukka Mäkinen
    Seinäjoki Central Hospital
    Hanneksenrinne 7
    FIN – 60220 Seinäjoki
    Finland
    E-mail: tuukka.makinen@epshp.fi
  • Dr. M. Lujan
    Dept. of Urology
    Hospital Universitario de Getafe
    Ctra Madrid Toledo Km, 12,5
    28905 GETAFE (Madrid)
    Spain
    Fax:+34.91.683.3271
    E-mail: marcoslujan@terra.es
  • Silas Pettersson
    Hovås Fasanstig 12
    436 50 HOVÅS
    Sweden
    E-mail: silas.pettersson@urology.gu.se
  • Eberhard Varenhorst
    Jacob Ekbohmsgatan11
    602 35 NORRKÖPING
    Sweden
    E-mail: varenhorst@telia.com
  • Prof. Dr. J. Hugosson
    Dept. of Urology
    Sahlgrenska University Hospital
    Bruna Straket 11
    S-413 45 Göteborg
    Sweden
    Fax: +46 31 4196 48
    E-mail: jonas.hugosson@urology.gu.se
  • Dr. M. Kwiatkowski
    Clinic of Urology
    Kantonspital Aarau
    Buchserstrasse
    CH-5001 Aarau
    Switzerland
    Fax: +41 62838 4753
    E-mail: maciej.kwiatkowski@ksa.ch
  • Dr. M. Soulie
    service d’urologie
    CHU rangueil Avenue Jean Poulhes
    31054 TOULOUSE CEDEX
    France
    Fax: + 33 5 6132 27 35.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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:

  1. To monitor the conduct of the study, adherence to trial design insofar as these are relevant to final co-ordinated analyses, which are;
    1. the analysis of prostate cancer mortality and the interpretation of these results
    2. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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).
  6. 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:

  1. 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.
  2. All centers use a standardised reporting form.
  3. 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.
  4. The reference pathologist reviews all needle biopsies of patients reported to have lesion of indeterminate malignancy, a precancerous lesion or an overt malignancy.
  5. 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