Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

NCT ID: NCT00738673

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix

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.

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Interventions

degarelix

Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Intervention Type: DRUG

Other Intervention Names

FE200486

Eligibility Criteria

Inclusion Criteria

• Patient has given written informed consent before any trial-related activity is performed.
• Patient is 18 years or older.
• Histologically confirmed prostate cancer.
• Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
• Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
• Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Estimated life expectancy at least 12 months.

Exclusion Criteria

• Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
• Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
• Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
• Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
• Known hypersensitivity towards any component of the investigational medical product.
• History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Known or suspected clinically significant liver and/or biliary disease.
• Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
• Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
• Previous participation in any degarelix trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Urologische Praxis

Bautzen, , Germany

Urologische Klinik

Berlin, , Germany

Urologische Praxis

Berlin, , Germany

Urologische Praxis

Borken, , Germany

Urologische Praxis

Cologne, , Germany

Urologische Praxis

Erkrath - Hochdal, , Germany

Urologische Praxis

Hagenow, , Germany

Martini Klinik

Hamburg, , Germany

Urologische Praxis

Husum, , Germany

Urologische Praxis

Kirchheim, , Germany

Urologische Praxis

Lauenburg/Elbe, , Germany

Urologische Praxis

Leipzig, , Germany

Urologische Praxis

Markkleeberg, , Germany

Urologische Klinik

Planegg, , Germany

Wissenschaftskontor Nord

Rostock, , Germany

Countries

Germany

Other Identifiers

2008-000585-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FE200486 CS27

Identifier Type: -

Identifier Source: org_study_id