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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01729676
Acronym
FACT
Enrollment
315
Registered
2012-11-20
Start date
2013-05-31
Completion date
2014-05-31
Last updated
2014-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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).

Interventions

DRUGDegarelix or GnRH agonist

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

Sponsors

Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Estimated percentage of different prostate cancer stages (overall and by region)During a single consultation when first-line prostate cancer hormone therapy is startedThe stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.

Secondary

MeasureTime frameDescription
The characteristics of the patients with prostate cancer by regionDuring a single consultation when first-line prostate cancer hormone therapy is startedCharacteristics 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 cancerDuring a single consultation when first-line prostate cancer hormone therapy is startedThe 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026