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

Study Overview
=================
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).

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix or GnRH agonist


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice | Drug: Degarelix or GnRH agonist<br>* Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice<br>|

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) | 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 | 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 | 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 |