Prostate CancerFACTNCT01729676
Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix or GnRH agonist
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men never previously treated with hormononal therapy for prostate cancer
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY
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).
- Conditions
- Prostate Cancer
- Being tested
- Degarelix or GnRH agonist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix or GnRH agonistDrug
Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice Receives: Drug: Degarelix or GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During a single consultation when first-line prostate cancer hormone therapy is started
Secondary outcomes (2)
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
Measured: 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).
Measured: During a single consultation when first-line prostate cancer hormone therapy is started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729676
- Sponsor's protocol ID
- 000059
- Acronym
- FACT
- Status last verified
- Jul 2014
- First submitted
- 23 Oct 2012
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY
- ClinicalTrials.gov ID
- NCT01729676
- Acronym / sponsor ID
- FACT / 000059
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Degarelix or GnRH agonistDegarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men never previously treated with hormononal therapy for prostate cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degarelix or GnRH agonistDegarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice | Drug | Group A |
Primary outcome
Estimated percentage of different prostate cancer stages (overall and by region)
Time frame: 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.
2 secondary outcomes
The characteristics of the patients with prostate cancer by region
Time frame: During a single consultation when first-line prostate cancer hormone therapy is started
The influence of regional factors on staging of prostate cancer
Time frame: During a single consultation when first-line prostate cancer hormone therapy is started
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated percentage of different prostate cancer stages (overall and by region) (time frame: During a single consultation when first-line prostate cancer hormone therapy is started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.