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NCT Number: NCT01221168

Epidemiologic and Genetic Study on Familial Prostate Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, CHU Angers, Angers, France

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About this study

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

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Performance of genetic and molecular factors in predicting the risk of prostate cancer

    Time frame: 20 years

    Logistic regression and artificial neural networks will be used

Study contacts

Contact information is provided by the study sponsor or research team.

Geraldine Cancel-Tassin, PhD

CONTACT

[email protected]

00 33 1 56 01 76 46

Olivier Cussenot, MD, PhD

CONTACT

[email protected]

00 33 1 56 01 76 46

Sponsors and collaborators

Lead sponsor

Centre de Recherche sur les Pathologies Prostatiques

Other

Registry information

Official study title

ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

Important dates

Study start
1996
Primary completion
2026
Study completion
2026
First posted
Oct 14, 2010
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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