Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Inclusion Criteria:

• Males aged 18 or over
• Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
• Has completed Study FE200486 CS07
• Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07