A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT01215526
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 274
- Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
- Patients with a contraindication for prescription of Firmagon®
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the progression-free survival (PFS) failure rate Maximum 3 years
- Secondary Outcome Measures
Name Time Method To prescribe the change in patient's quality of life (QoL) during therapy. From study start and after 6 months 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) 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 To assess the reduction of prostate volume (neoadjuvant therapy) Fom baseline after 3 months
Trial Locations
- Locations (45)
Flevoziekenhuis
🇳🇱Almere, Netherlands
Bovenij Ziekenhuis
🇳🇱Amsterdam, Netherlands
Wilhelminaziekenhuis
🇳🇱Assen, Netherlands
Rode Kruis Ziekenhuis
🇳🇱Beverwijk, Netherlands
Tergooiziekenhuizen
🇳🇱Hilversum, Netherlands
Ljsselland Ziekenhuis
🇳🇱Capelle aan den IJssel, Netherlands
Jeroen Bosch Ziekenhuis, locatie Carolus
🇳🇱Den Bosch, Netherlands
Hagaziekenhuis loc. Leyweg
🇳🇱Den Haag, Netherlands
Hagaziekenhuis loc. Sportlaan
🇳🇱Den Haag, Netherlands
Alb.Schweitzer Ziekenhuis, loc. Dordwijk
🇳🇱Dordrecht, Netherlands
Gelderse Vallei, loc. Barneveld
🇳🇱Ede, Netherlands
St. Anna Ziekenhuis
🇳🇱Geldrop, Netherlands
Admiraal de Ruyter Ziekenhuis
🇳🇱Vlissingen, Netherlands
Buitenpolikliniek
🇳🇱Groenlo, Netherlands
Ziekenhuis St Jansdal
🇳🇱Harderwijk, Netherlands
LUMC
🇳🇱Leiden, Netherlands
Rijnland Ziekenhuis
🇳🇱Leiderdorp, Netherlands
MUMC
🇳🇱Maastricht, Netherlands
Vlietland Ziekenhuis
🇳🇱Rotterdam, Netherlands
Alb. Schweitzer Ziekenhuis loc. Sliedrecht
🇳🇱Sliedrecht, Netherlands
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
Ruwaard v Putten/vWeel Bethesda Zkhs
🇳🇱Spijkenisse, Netherlands
Ziekenhuis Bernhoven, loc. Veghel
🇳🇱Veghel, Netherlands
St. Jans Gasthuis
🇳🇱Weert, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Zwijndrecht, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Reinier de Graaf Groep
🇳🇱Delft, Netherlands
Deventer Ziekenhuis
🇳🇱Deventer, Netherlands
Slingeland Ziekenhuis
🇳🇱Doetinchem, Netherlands
Rivas Beatrixziekenhuis
🇳🇱Gorinchem, Netherlands
Het Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Elkerliek Ziekenhuis
🇳🇱Helmond, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Ziekenhuis Bernhoven, loc. Oss
🇳🇱Oss, Netherlands
Waterland Ziekenhuis
🇳🇱Purmerend, Netherlands
Franciscus Ziekenhuis
🇳🇱Roosendaal, Netherlands
Havenziekenhuis
🇳🇱Rotterdam, Netherlands
Orbis Medisch Centrum
🇳🇱Sittard-Geleen, Netherlands
Zorgzaam Ziekenhuis
🇳🇱Terneuzen, Netherlands
Ziekenhuis Rivierenland
🇳🇱Tiel, Netherlands
Antonius Ziekenhuis, loc. Oudenrijn
🇳🇱Utrecht, Netherlands
Diakonessenhuis Utrecht
🇳🇱Utrecht, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands