Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

Ferring Pharmaceuticals127 enrolled

Overview

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Prostate Cancer

Interventions

DegarelixDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient * Has completed the 7-month main trial, FE200486 CS42 Exclusion Criteria: * Has been withdrawn/discontinued from the FE200486 CS42 trial * A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

Locations (11)

Korea University Hospital

Seoul, Anam-dong, Seongbuk-gu, South Korea

Seoul St. Mary's Hospital

Seoul, Banpo-dong, Seocho-gu, South Korea

Kyoungbuk National University Hospital

Daegu, Daegu, South Korea

Outcomes

Primary Outcomes

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal

Time frame: From baseline (day 0) to end of treatment (up to day 364)

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Time frame: From baseline (day 0) to end of treatment (up to day 364)

Number of Participants With Markedly Abnormal Values in ECG Variables

This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Time frame: From baseline (day 0) to end of treatment (up to day 364)

Secondary Outcomes

Serum Levels of Prostate Specific Antigen (PSA) Over Time

PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).

Time frame: Day 0, day 196, day 280, and day 364

Data from ClinicalTrials.gov

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