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Completed

NCT Number: NCT01729676

Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital Robert Boulin

Libourne, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with histologically demonstrated prostatic adenocarcinoma.
  • Patients never previously treated with hormonal therapy for prostate cancer.
  • Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
  • Patients agreeing to the collection of personal health data for the purposes of the study.
  • Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.

Exclusion criteria

  • Patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation.
  • Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).

Treatment and study plan

Degarelix or GnRH agonist

Drug

Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice

Primary outcomes

  1. Estimated percentage of different prostate cancer stages (overall and by region)

    Time frame: During a single consultation when first-line prostate cancer hormone therapy is started

    The stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.

Secondary outcomes

  1. The characteristics of the patients with prostate cancer by region

    Time frame: During a single consultation when first-line prostate cancer hormone therapy is started

    Characteristics are described by demography, tumour characteristics, Gleason score, D'Amico score, prostate specific antigen (PSA), Testosterone and treatment history

  2. The influence of regional factors on staging of prostate cancer

    Time frame: During a single consultation when first-line prostate cancer hormone therapy is started

    The regional influence will be demonstrated by modelling the probability of a patient being at one of the cancer stages (locally advanced cancer, metastatic cancer, biological recurrence).

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY

Acronym: FACT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2012
Registry last updated
Jul 17, 2014

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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