Conditions: Prostate Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 220
Healthy volunteers: no

Brief summary:
The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

Detailed description:
The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA \>4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Arms:
arm 1: None

Interventions: intervention 1: Degarelix 240 mg / 80 mg
Intervention descriptions: intervention 1: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.

Protocol document: