Clinical trial NCT01215526: A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer
Official title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 274
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced prostate cancer

Brief 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.


Eligibility criteria: Inclusion Criteria:

- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy

Exclusion Criteria:

- Patients with a contraindication for prescription of Firmagon®

Primary outcomes:
measure: To estimate the progression-free survival (PFS) failure rate
timeFrame: Maximum 3 years
Secondary outcomes:
measure: To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects
timeFrame: Every 3 months (during 3 years)
measure: To prescribe the change in patient's quality of life (QoL) during therapy.
timeFrame: From study start and after 6 months
measure: To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy
timeFrame: From study start, after 3 months and at end of treatment
measure: To assess the reduction of prostate volume (neoadjuvant therapy)
timeFrame: Fom baseline after 3 months
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Bovenij Ziekenhuis
city: Assen
country: Netherlands
facility: Wilhelminaziekenhuis
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Capelle aan den IJssel
country: Netherlands
facility: Ljsselland Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis, locatie Carolus
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis loc. Leyweg
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis loc. Sportlaan
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Alb.Schweitzer Ziekenhuis, loc. Dordwijk
city: Ede
country: Netherlands
facility: Gelderse Vallei, loc. Barneveld
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Rivas Beatrixziekenhuis
city: Gouda
country: Netherlands
facility: Het Groene Hart Ziekenhuis
city: Groenlo
country: Netherlands
facility: Buitenpolikliniek
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St Jansdal
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: LUMC
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Maastricht
country: Netherlands
facility: MUMC
city: Oss
country: Netherlands
facility: Ziekenhuis Bernhoven, loc. Oss
city: Purmerend
country: Netherlands
facility: Waterland Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Franciscus Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Havenziekenhuis
city: Rotterdam
country: Netherlands
facility: Vlietland Ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Centrum
city: Sliedrecht
country: Netherlands
facility: Alb. Schweitzer Ziekenhuis loc. Sliedrecht
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Spijkenisse
country: Netherlands
facility: Ruwaard v Putten/vWeel Bethesda Zkhs
city: Terneuzen
country: Netherlands
facility: Zorgzaam Ziekenhuis
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
city: Utrecht
country: Netherlands
facility: Antonius Ziekenhuis, loc. Oudenrijn
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Veghel
country: Netherlands
facility: Ziekenhuis Bernhoven, loc. Veghel
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Vlissingen
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Weert
country: Netherlands
facility: St. Jans Gasthuis
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: