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

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix or GnRH agonist

• Registration Number: NCT01729676
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 315

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Estimated percentage of different prostate cancer stages (overall and by region)	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 Outcome Measures

Name	Time	Method
The characteristics of the patients with prostate cancer by region	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
The influence of regional factors on staging of prostate cancer	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).

Trial Locations

Locations (1)

Hôpital Robert Boulin; 🇫🇷 Libourne, France