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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Jeroen Bosch Ziekenhuis, locatie Carolus, 's-Hertogenbosch, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Primary outcomes

To estimate the progression-free survival (PFS) failure rate

Time frame: Maximum 3 years

Secondary outcomes

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)
To prescribe the change in patient's quality of life (QoL) during therapy.

Time frame: From study start and after 6 months
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
To assess the reduction of prostate volume (neoadjuvant therapy)

Time frame: Fom baseline after 3 months

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: FAST-NL

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 6, 2010
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed