A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer

Prostate Cancer Clinical Trial

— FAST-NL  

Official title:

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215526
• Other study ID #: FE200486 CS46
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: August 18, 2015
• Start date: October 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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®

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Bovenij Ziekenhuis	Amsterdam
Netherlands	Wilhelminaziekenhuis	Assen
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Tergooiziekenhuizen	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Ljsselland Ziekenhuis	Capelle aan den IJssel
Netherlands	Reinier de Graaf Groep	Delft
Netherlands	Jeroen Bosch Ziekenhuis, locatie Carolus	Den Bosch
Netherlands	Hagaziekenhuis loc. Leyweg	Den Haag
Netherlands	Hagaziekenhuis loc. Sportlaan	Den Haag
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	Alb.Schweitzer Ziekenhuis, loc. Dordwijk	Dordrecht
Netherlands	Gelderse Vallei, loc. Barneveld	Ede
Netherlands	St. Anna Ziekenhuis	Geldrop
Netherlands	Admiraal de Ruyter Ziekenhuis	Goes
Netherlands	Rivas Beatrixziekenhuis	Gorinchem
Netherlands	Het Groene Hart Ziekenhuis	Gouda
Netherlands	Buitenpolikliniek	Groenlo
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Ziekenhuis St Jansdal	Harderwijk
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Tergooiziekenhuizen	Hilversum
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	LUMC	Leiden
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	MUMC	Maastricht
Netherlands	Ziekenhuis Bernhoven, loc. Oss	Oss
Netherlands	Waterland Ziekenhuis	Purmerend
Netherlands	Franciscus Ziekenhuis	Roosendaal
Netherlands	Havenziekenhuis	Rotterdam
Netherlands	Vlietland Ziekenhuis	Rotterdam
Netherlands	Orbis Medisch Centrum	Sittard-Geleen
Netherlands	Alb. Schweitzer Ziekenhuis loc. Sliedrecht	Sliedrecht
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	Ruwaard v Putten/vWeel Bethesda Zkhs	Spijkenisse
Netherlands	Zorgzaam Ziekenhuis	Terneuzen
Netherlands	Ziekenhuis Rivierenland	Tiel
Netherlands	Antonius Ziekenhuis, loc. Oudenrijn	Utrecht
Netherlands	Diakonessenhuis Utrecht	Utrecht
Netherlands	Ziekenhuis Bernhoven, loc. Veghel	Veghel
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	Admiraal de Ruyter Ziekenhuis	Vlissingen
Netherlands	St. Jans Gasthuis	Weert
Netherlands	Albert Schweitzer Ziekenhuis	Zwijndrecht
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the progression-free survival (PFS) failure rate		Maximum 3 years	No
Secondary	To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects		Every 3 months (during 3 years)	No
Secondary	To prescribe the change in patient's quality of life (QoL) during therapy.		From study start and after 6 months	No
Secondary	To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy		From study start, after 3 months and at end of treatment	No
Secondary	To assess the reduction of prostate volume (neoadjuvant therapy)		Fom baseline after 3 months	No