Prostate CancerFAST-NLNCT01215526
A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 47 sites in Netherlands.
Trial summary
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 274 participants
- Where
- 47 sitesNetherlands
- Study dates
- Oct 2010to Jul 2015
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced prostate cancer
Who may be able to join
- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
Who cannot join
- Patients with a contraindication for prescription of Firmagon®
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Netherlands47 sites
Jeroen Bosch Ziekenhuis, locatie Carolus
's-Hertogenbosch
Flevoziekenhuis
Almere Stad
Bovenij Ziekenhuis
Amsterdam
Wilhelminaziekenhuis
Assen
Rode Kruis Ziekenhuis
Beverwijk
Tergooiziekenhuizen
Blaricum
Amphia Ziekenhuis
Breda
Ljsselland Ziekenhuis
Capelle aan den IJssel
Reinier de Graaf Groep
Delft
Deventer Ziekenhuis
Deventer
Slingeland Ziekenhuis
Doetinchem
Alb.Schweitzer Ziekenhuis, loc. Dordwijk
Dordrecht
Gelderse Vallei, loc. Barneveld
Ede
Admiraal de Ruyter Ziekenhuis
Flushing
St. Anna Ziekenhuis
Geldrop
Admiraal de Ruyter Ziekenhuis
Goes
Rivas Beatrixziekenhuis
Gorinchem
Het Groene Hart Ziekenhuis
Gouda
Buitenpolikliniek
Groenlo
Martini Ziekenhuis
Groningen
Ziekenhuis St Jansdal
Harderwijk
Elkerliek Ziekenhuis
Helmond
Tergooiziekenhuizen
Hilversum
Medisch Centrum Leeuwarden
Leeuwarden
LUMC
Leiden
Rijnland Ziekenhuis
Leiderdorp
MUMC
Maastricht
Ziekenhuis Bernhoven, loc. Oss
Oss
Waterland Ziekenhuis
Purmerend
Franciscus Ziekenhuis
Roosendaal
Havenziekenhuis
Rotterdam
Vlietland Ziekenhuis
Rotterdam
Orbis Medisch Centrum
Sittard-Geleen
Alb. Schweitzer Ziekenhuis loc. Sliedrecht
Sliedrecht
Antonius Ziekenhuis
Sneek
Ruwaard v Putten/vWeel Bethesda Zkhs
Spijkenisse
Zorgzaam Ziekenhuis
Terneuzen
Hagaziekenhuis loc. Leyweg
The Hague
Hagaziekenhuis loc. Sportlaan
The Hague
Ziekenhuis Rivierenland
Tiel
Antonius Ziekenhuis, loc. Oudenrijn
Utrecht
Diakonessenhuis Utrecht
Utrecht
Ziekenhuis Bernhoven, loc. Veghel
Veghel
Maxima Medisch Centrum
Veldhoven
St. Jans Gasthuis
Weert
Albert Schweitzer Ziekenhuis
Zwijndrecht
Isala Klinieken
Zwolle
About this study
Official title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the progression-free survival (PFS) failure rate
Measured: Maximum 3 years
Secondary outcomes (4)
To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects
Measured: Every 3 months (during 3 years)
To prescribe the change in patient's quality of life (QoL) during therapy.
Measured: From study start and after 6 months
To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy
Measured: From study start, after 3 months and at end of treatment
To assess the reduction of prostate volume (neoadjuvant therapy)
Measured: Fom baseline after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2015
- Study completionJul 2015
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
- 274 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
- NCT01215526
- Sponsor's protocol ID
- FE200486 CS46
- Acronym
- FAST-NL
- Status last verified
- Aug 2015
- First submitted
- 5 Oct 2010
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands
- ClinicalTrials.gov ID
- NCT01215526
- Acronym / sponsor ID
- FAST-NL / FE200486 CS46
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Oct 2010 (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.
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced prostate cancer
Key inclusion criteria (1 listed)
- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
Key exclusion criteria (1 listed)
- Patients with a contraindication for prescription of Firmagon®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the progression-free survival (PFS) failure rate
Time frame: Maximum 3 years
4 secondary outcomes
To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects
Time frame: Every 3 months (during 3 years)
To prescribe the change in patient's quality of life (QoL) during therapy.
Time frame: From study start and after 6 months
To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy
Time frame: From study start, after 3 months and at end of treatment
To assess the reduction of prostate volume (neoadjuvant therapy)
Time frame: Fom baseline after 3 months
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 19 Aug 2015.
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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
47 sites 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 47 sites in Netherlands.
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 1 inclusion and 1 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Netherlands. 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?
To estimate the progression-free survival (PFS) failure rate (time frame: Maximum 3 years). 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 19 Aug 2015.