A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer (FAST-NL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01215526
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
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.

Condition or disease
Prostate Cancer

Study Type : Observational
Actual Enrollment : 274 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands
Study Start Date : October 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. To estimate the progression-free survival (PFS) failure rate [ Time Frame: Maximum 3 years ]

Secondary Outcome Measures :
  1. 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) ]
  2. To prescribe the change in patient's quality of life (QoL) during therapy. [ Time Frame: From study start and after 6 months ]
  3. 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 ]
  4. To assess the reduction of prostate volume (neoadjuvant therapy) [ Time Frame: Fom baseline after 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced prostate cancer

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01215526

Almere, Netherlands
Bovenij Ziekenhuis
Amsterdam, Netherlands
Assen, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
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
Groenlo, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Ziekenhuis St Jansdal
Harderwijk, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Hilversum, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leiden, Netherlands
Rijnland Ziekenhuis
Leiderdorp, Netherlands
Maastricht, Netherlands
Ziekenhuis Bernhoven, loc. Oss
Oss, Netherlands
Waterland Ziekenhuis
Purmerend, Netherlands
Franciscus Ziekenhuis
Roosendaal, Netherlands
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, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01215526     History of Changes
Other Study ID Numbers: FE200486 CS46
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases