An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy

• Conditions: Prostate Cancer; MedDRA version: 9.1Level: LLTClassification code 10007113Term: Cancer of prostate

• Registration Number: EUCTR2007-006055-39-FI
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 540

Inclusion Criteria

1. Has given written informed consent before any study-related activity is performed. A study-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), in which androgen ablation treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.

3. Is a male patient aged 18 years or older.

4. Has a screening serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.

5. Has an ECOG (Eastern Co-operative Oncology Group) score of =2 (see Section 5.2.5).

6. Has a screening PSA value of =2 ng/mL.

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

1. Has had previously 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). 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 a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms).

6. Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).

7. Is taking concomitant medications that prolong the QT/QTcF interval.

8. Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.

9. Has a known or suspected clinically significant liver and/or biliary disease.

10. Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient’s health or the outcome of the study.

11. Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse, which may affect the patient’s health or the outcome of the study as judged by the investigator.

12. Has a mental incapacity or language barriers precluding adequate understanding or co-operation.

13. 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 study.

14. Has previously participated in any degarelix study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. ;Secondary Objective: -To evaluate testosterone, PSA, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) responses during one year of treatment.<br><br>-To evaluate pharmacokinetic response.<br><br>-To compare safety and tolerability profiles of different degarelix three-month dosing regimens.;Primary end point(s): Probability of testosterone at castration level (=0.5 ng/mL) from Day 28 through Day 364.