Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

A 12 week (84 day) single injection study in 12 patients with carcinoma of the prostate. During the screening phase, all patients will come to the clinic for a screening visit (V1), during which the patient's eligibility will be evaluated and baseline assessments will be performed. Eligible patients will sign the informed consent form at this visit. Within 2 weeks after the screening visit, eligible patients will receive a subcutaneous injection of Pepti 10.8mg on day 0 (V2) and samples will be collected for goserelin 1h, 1.5h, 2h and 3h after the injection. Monitoring of the effects for approximate 4h after the injection will be performed. Thereafter, patients will return to the clinic for follow-up visits approximately every 2 weeks (Visit 3 to 9: Day 7, 21, 35, 49, 63, 77 and 84). The follow-up visits are planned to enable repeated blood sampling designed to evaluate the testosterone response, safety profile and PSA response.