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

Prostate Cancer Clinical Trial

— FACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729676
• Other study ID #: 000059
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: July 16, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Robert Boulin	Libourne

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No