Prostate Cancer MedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient 2. Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment 3. A. Patients with Locally Advanced or Metastatic Prostate Cancer Screening PSA level (measured at a central laboratory) must be >4 ng/mL and =50 ng/mL 3. B. Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA PSA doubling time (based on patient records at the trial site) must be =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, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then 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 Screening Visit. 2. Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy. 3. Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 4. Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. 6. Has a known or suspected clinically significant liver and/or biliary disease. 7. Has a corrected QT interval (using the Fridericia correction method) over 450 msec. 8. Has a history of or risk factors for Torsades de Pointes 9. Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient’s health or the outcome of the trial. 10. 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. 11. Has a mental incapacity or language barriers precluding adequate understanding or co operation. 12. Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial. 13. Has previously participated in any degarelix trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patients;Secondary Objective: To evaluate the time to PSA >4 ng/mL during the second and subsequent cycles of IAD after the end of an induction period with degarelix (d) To evaluate the time to PSA >4 ng/mL during the first cycle of IAD in patient sub-groups To determine the time to return to age-adjusted lower limit of normal range or baseline level of testosterone during the first and subsequent cycles of IAD after the end of an induction period with d To evaluate disease specific Quality of Life during the induction d treatment and off-treatment periods during the first and subsequent cycles of IAD To evaluate sexual function during the induction d treatment and off-treatment periods during the first and subsequent cycles of IAD To evaluate safety and tolerability during the induction d treatment and off-treatment periods during the first and subsequent cycles of IAD;Primary end point(s): Median and between patient variability of time to PSA >4 ng/mL during the first cycle of IAD after 7 monthly injections of degarelix induction treatment | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Outcome results
None listed