Location of Administrative Centers:
ADIMEP (Association pour la Diffusion de la Médecine de Prévention),
66 Chemin du Vallon B.P. 4420
31405 TOULOUSE Cedex
Tel: 33 5 62 17 39 05
Fax : 33 5 62 17 39 01
ARCOU (Association de Recherche et de Consensus en
Onco-Urologie Languedoc Roussillon)
119 avenue de Lodève
Tel : 04 67 75 97 57
Fax : 05 67 75 97 65
Pr Arnauld VILLERS
Service d’urologie CHRU 59037 LILLE
Téléphone : 03 20 44 42 35
Funding et promotion and partners
Promoteur : ARCOU (Association de Recherche et de Consensus en Onco-Urologie – Languedoc Roussillon) and Centre Hospitalo-Universitaire de Toulouse.
Funding: Major funding by URCAM (Union régionale des caisses d’assurance maladie) Languedoc Roussillon(FAQSV 2002) and Midi Pyrénées (FAQSV 2002). Other fundings by Association Française d’Urologie (AFU), CHU of Toulouse (AOL 1998-20-L, AOL 2001), Ligue départementale contre le Cancer de l’Hérault and Association pour la Recherche sur les Tumeurs Prostatiques (ARTP).
Institut National du Cancer 2008 Convention : 07/3D1616/SPC-111-13/NG-NC
Ligue Nationale Contre le Cancer 2008 et 2014
Registre des cancers du Tarn
ONCOMIP – Réseau de cancérologie de Midi-Pyrénées
1, Avenue Irène Joliot Curie I.U.C.T-O 31 059 Toulouse Cedex 9
Tel. : 05 31 15 65 01 Fax : 05 31 15 65 23
Courrier : email@example.com
ADIMEP (Association pour la Diffusion de la Médecine de Prévention) Registre des Cancers du Tarn CHG Castres-Mazamet
ARCOU Registre des Tumeurs de l’Herault Depistages 34
Local ERSPC protocol foresees:
The two principal objectives of the European study are mortality during at least 10 years of post-screening follow-up and quality of life of those patients with prostate cancer in each group of men.
The examination of 2 650 men was envisaged in the feasibility study, this representing about 10 % of the total of 30 560 men aged 55 to 69 years in the Tarn department population. The whole study will include 101 300 men 55 to 69 years from Tarn (30 560) and Hérault (70 740) which will be studied during three years (2003 to 2005).
Method of investigation:
Individual randomization within the whole population of controls and screened, mailing of aninformation form together with a form of consent, followed on reception of the form of consent, by mailing of a notification to go to the local laboratory for a blood sample, then centralized testing for total and free PSA (Hybritech test). Centralized processing of the results and mailing of the result to the person tested and to his general practitioner, and necessity of a DRE and TRUS guided sextant prostate biopsy to be performed by one of the 7 co-investigator urologists in the Tarn if the PSA level > 3 ng/ml. Results of biopsies, investigation of satisfaction by mailing. Recommendation for the GP not to perform opportunistic screening by PSA in both control and screened groups but re screen two years by the study group. Permanent follow-up by the Tarn Cancer Register (new cases, death certificates and patient charts).
Origin and nature of the nominative data collected:
The ADIMEP and DEPISTAGE 34 (administrative structures) are to compile a data base of the people taking part in the screening study. This data base will be compiled from information obtained from the electoral registers of the Tarn department: name, first name, date and place of birth and address of the individuals selected (men aged 55 to 69 years).
Justification of the recourse to nominative data:
Cross analysis of the data base and the Cancer Register at the beginning of the study and during it will be able to demonstrate any cases of prostate cancer within the populations of the Tarn and Hérault.
Information about these cancers:
nature and circumstances of the diagnosis, clinical stage, treatments administered, tumour stage, cause and date of possible death, will be collected as part of the permanent enquiry associated with the Tarn and Hérault Cancer Register and recorded in the data base.
Duration and mode of organization of the research:
The feasibility study was carried out over one year (year 2001). The assessment of feasibility was made after one year. In the absence of positive exclusion criteria, the study will be continued by including the total number of men over the following three years. At least 10 years of follow-up are envisaged after the screening study to determine the specific mortality due to prostate cancer in each group. The database will record the consent, refusal or non response of the men invited to take part in the screening study. For the men who have done an PSA test, the results of this test will be recorded together with the answers to the questionnaire concerning urinary problems. For the men with abnormal PSA results, the results of the biopsies performed by the urologists will be recorded, together with the information from the questionnaire sent to the patient after his biopsy.
Methods of data analysis :
Results of feasibility study : Response rate was 53 %, participation rate was 40 %. 17 % of men had PSA > 3ng/ml. 90 % accepted the biopsy. Mean PSA total, free et % free/total were respectively 1,92 ng/ml, 0,40 ng/ml et 26,5%. Cancer detection rate was 4 %. The judgment criteria, selected at the European level, have as principal objective on completion of the study, to reduce the mortality due to prostate cancer in 10 years. As for the intermediate results : the value of the screening test, assessment of the complications associated with screening, the evolution of survival with complete remission in the screened and unscreened groups, the evolution of survival without metastases in the screened and unscreened groups, and evolution of the quality of life in the screened and unscreened groups.
Centralized collection of the data and analysis by the European multi local study group:
The statistical analysis will be carried out by the data analysis committee. The data from different countries will be addressed in non-nominative form, in a specified computerized format. The other committees in the European study include the quality control committee, the epidemiological committee, the PSA committee, the causes of death committee, and the pathology committee. They are solely concerned with the methodology study.