A Trial of Degarelix in Patients With Prostate Cancer

Ferring

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Degarelix

Drug: Goserelin acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00946920

2008-005276-27 (EudraCT Number)

FE200486 CS35

Details and patient eligibility

About

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Enrollment

859 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older.
Has a histological confirmed prostate cancer Gleason graded).
Has a screening testosterone above 2.2 ng/mL.
Rising prostate-specific antigen (PSA).
Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
Has a life expectancy of at least one year.

Exclusion criteria

Current or previous hormone therapy.
Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Has a heart insufficiency.
Has a 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.
Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, 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.
Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.