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

July 16, 2014 updated by: Ferring Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Libourne, France
        • Hôpital Robert Boulin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men never previously treated with hormononal therapy for prostate cancer

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice
Drug: Degarelix or GnRH agonist
Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During a single consultation when first-line prostate cancer hormone therapy is started

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During a single consultation when first-line prostate cancer hormone therapy is started
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).
During a single consultation when first-line prostate cancer hormone therapy is started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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