Conditions: Prostate Cancer
Keywords: Hormone refractory prostate cancer Agonist treatment failure
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief summary:
This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Detailed description:

Arms:
arm 1: Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0.

Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Interventions: intervention 1: degarelix
Intervention descriptions: intervention 1: Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Protocol document: