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).
Partners :
Tarn :
ADIMEP (Association pour la Diffusion de la Médecine de Prévention)
Registre des Cancers du Tarn
CHG Castres-Mazamet
Hérault :
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.
Test population:
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 an information 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.
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