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: Patient has given written informed consent before any trial-related activity is performed. Patient is 18 years or older. Planned for radical radiotherapy treatment and in whom neoadjuvant endocrine treatment is indicated. Tumour, Nodule, and Metastatic (TNM) stage T2 (b or c)/T3/T4, N0, M0; or Gleason score = 7 or PSA = 10 ng/ml. Eastern Co-operative Oncology Group (ECOG) score of ? 2. Estimated life expectancy at least 30 months. Prostate size > 30 cubic centimetres, measured by TRUS. 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: Any previous treatment for prostate cancer. Previous trans-urethral resection of the prostate. Patients who are lymph node positive or have other metastatic disease. Use of urethral catheter. Is not considered a candidate for hormonal therapy as neoadjuvant treatment to radiotherapy. Is currently treated with a 5-alpha reductase inhibitor. If the patient has been treated with a 5-alpha reductase inhibitor the treatment must have stopped at least 6 months prior to this study. Is currently treated with an a-adrenoceptor antagonist. If the patient has been treated with an a-adrenoceptor antagonist the treatment must have stopped at least 8 weeks prior to this study. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. Hypersensitivity towards any component of the investigational products. 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 corrected QT interval (using the Fridericia correction method) over 450 msec. Has a history of or risk factors for Torsades de Pointes At time of inclusion receive concomitant medications that might prolong the QT interval 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. Mental incapacity or language barrier precluding adequate understanding or co-operation. Receipt of an investigational drug within the last 28 days proceeding screening or longer if considered to possibly influence the outcome of the current trial. Previous participation in any degarelix trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the mean percentage reduction in prostate volume with degarelix is non-inferior to goserelin plus bicalutamide, based on a trans-rectal ultrasound scan (TRUS) at 12 weeks (Visit 5=End of Trial [EoT] Visit) compared to baseline (Visit 2 - Randomisation) ;Secondary Objective: To demonstrate that lower urinary tract symptom (LUTS) relief with degarelix is non-inferior to goserelin plus bicalutamide, based on a reduction in International Prostate Symptom Score (IPSS) at 4, 8, and 12 weeks as compared to baseline To follow testosterone control after treatment with degarelix compared with goserelin plus bicalutamide, based on serum testosterone level measurements taken at baseline, 4, 8, and 12 weeks To follow prostate-specific antigen (PSA) control after treatment with degarelix compared with goserelin plus bicalutamide, based on serum PSA level measurements taken at baseline, 4, 8, and 12 weeks To measure oestradiol levels after treatment with degarelix compared with goserelin plus bicalutamide at baseline, 4, 8, 12 weeks To compare quality of life due to urinary symptoms at 4, 8, and 12 weeks to baseline based on the additional question on the IPSS To compare the safety of degarelix and goserelin plus bicalutamide treatments ;Primary end point(s): Mean percentage reduction in prostate volume at 12 weeks as compared to baseline | — |
Countries
France, Germany, Greece, Netherlands, Spain, United Kingdom
Outcome results
None listed