The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

Ferring

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819247

FE200486 CS02

Details and patient eligibility

About

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Full description

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.

Enrollment: 129 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent before any trial related activity
• Proven prostate cancer with a need for endocrine treatment
• Testosterone level within the normal range for the age

Exclusion criteria

• Previous or current hormonal treatment of prostate cancer
• Candidate for prostatectomy or radiotherapy
• History of severe asthma, anaphylactic reactions or Quincke's Oedema
• Hypersensitivity towards any component of FE200486
• Cancer disease within the last ten years except for prostate cancer and some skin cancers
• Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
• Mental incapacity or language barrier
• Having received an investigational product within the last 12 weeks preceding the trial
• Previous participation in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 3 patient groups

Degarelix 80/80 + 40

Experimental group

Description:

Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.

Treatment:

Drug: Degarelix

Degarelix 40/40 + 40

Experimental group

Description:

Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.

Treatment:

Drug: Degarelix

Degarelix 80 + 20

Experimental group

Description:

Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.

Treatment:

Drug: Degarelix