Epidemiologic and Genetic Study on Familial Prostate Cancer

• Conditions: Prostate Cancer

• Registration Number: NCT01221168
• Lead Sponsor: Centre de Recherche sur les Pathologies Prostatiques

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.

Study Timeline

• Study Start: 1996-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of genetic and molecular factors in predicting the risk of prostate cancer	20 years	Logistic regression and artificial neural networks will be used

Trial Locations

Locations (5)

Department of Urology, Hopital de la Cavale Blanche; 🇫🇷 Brest, France

Department of Urology, CHU Dijon; 🇫🇷 Dijon, France

Department of Urology, Hopital Tenon; 🇫🇷 Paris, France

Department of Urology, CHU Angers; 🇫🇷 Angers, France

Department of Urology, Hopital Pitié-Salpetriere; 🇫🇷 Paris, France