Clinical trial NCT01221168: Epidemiologic and Genetic Study on Familial Prostate Cancer
Official title: ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: prostate
cancer
genetic
epidemiology
susceptibility
Lead sponsor: Centre de Recherche sur les Pathologies Prostatiques
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with or without prostate cancer are recruited in different departments of urology or care centers in France.

For hereditary prostate cancer, patients and their family members are referred by all urologists from France.

Brief summary: The aims of the study are:

* to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
* to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

Detailed description: The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:

1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy).
2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance).

The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples:

* For men with known prostate cancer.
* For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.

The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Eligibility criteria: Inclusion Criteria:

* patient with a histological confirmed prostate cancer
* member of a hereditary prostate cancer family
* healthy control men without prostate cancer

Exclusion Criteria:

* Absence of signed informed consent
* refusal to participate in the study

Primary outcomes:
measure: Performance of genetic and molecular factors in predicting the risk of prostate cancer
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Department of Urology, CHU Angers
city: Brest
country: France
facility: Department of Urology, Hopital de la Cavale Blanche
city: Dijon
country: France
facility: Department of Urology, CHU Dijon
city: Paris
country: France
facility: Department of Urology, Hopital Pitié-Salpetriere
city: Paris
country: France
facility: Department of Urology, Hopital Tenon
Study officials:
affiliation: Centre de Recherche sur les Pathologies Prostatiques
name: Olivier Cussenot, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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