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

NCT ID: NCT01729676

Last Updated: 2014-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice

Degarelix or GnRH agonist

Intervention Type DRUG

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

Interventions

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Degarelix or GnRH agonist

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Hôpital Robert Boulin

Libourne, , France

Site Status

Countries

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France

Other Identifiers

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000059

Identifier Type: -

Identifier Source: org_study_id

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