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

Completed

• 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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 274

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

• 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

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

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