prostate cancer MedDRA version: 9.1 Level: PT Classification code 10060862 Term: Prostate cancer
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Has given written informed consent before any trial-related activity is performed. The patients in the sub-group who will perform the extra degarelix plasma concentration assessments will have to provide separate informed consent covering these extra visits. 2.Has a histologically confirmed adenocarcinoma of the prostate for which endocrine treatment (except for neoadjuvant hormonal therapy) is indicated (this includes patients having undergone prostatectomy or radiotherapy with curative intention and have a rising PSA). For patients having undergone prostatectomy/cryotherapy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit. 3. Has a PSA level meeting one of these criteria: For treatment-naïve patients: Patients should have a screening PSA level of =2 ng/mL. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of =0.2 ng/mL from the previous test on two consecutive measurements. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir. 4.Is 18 years of age or older. 5.Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >2.2 ng/mL. 6.Has an Eastern Cooperative Oncology Group score of =2. 7.Has a life expectancy of at least one year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole). However, for patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit. 2. Has received therapy with the 5-alpha reductase inhibitors finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening. 3.Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy. 4.Is in need of neoadjuvant hormonal therapy. 5.Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy. 6.Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 7.Has hypersensitivity towards any component of the investigational medicinal product or excipients. 8.Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms). 9.Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome). 10.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. 11.Has any clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient’s health or the outcome of the trial. 12.Has a clinically significant disorder (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. 13.Incomplete recovery from the effects of any major surgery. 14.Has a mental incapacity or language barrier precluding adequate understanding or co operation. 15.Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial. 16.Has previously participated in any degarelix trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression =0.5 ng/mL from Day 28 to Day 364 (primary objective recommended by the FDA) •To establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) from Day 3 to Day 364 (primary objective recommended by the EMEA) ;Secondary Objective: •To evaluate treatment response as the ability to achieve and maintain testosterone suppression to castrate levels, and to remain in the trial without AEs that would lead to withdrawal (including treatment-emergent deaths) from Day 3 to Day 364 •To compare degarelix to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) from Day 28 to Day 364 •To compare degarelix to goserelin with regard to testosterone suppression at castrate levels (=0.5 ng/mL) from Day 56 to Day 364 •To evaluate testosterone, PSA and LH responses of degarelix or goserelin treatment •To compare degarelix to goserelin with regard to the occurrences of microsurges, PSA failure, overall death, disease progression, changes in patient related outcome, i.e. overall Health Related Quality of Life, arthralgia and urinary symptom relief •To compare safety and tolerability profiles of the two drugs;Primary end point(s): •Cumulative probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 to Day 364 with degarelix •Difference in cumulative probability of testosterone at castrate level (=0.5 ng/mL) from Day 3 to Day 364 between degarelix and goserelin | — |
Countries
Belgium, Czech Republic, Finland, Germany, Hungary, Netherlands, United Kingdom
Outcome results
None listed