An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy - FE200486 CS29

• Conditions: Prostate Cancer; MedDRA version: 14.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-003931-19-NL
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-17
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

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 <24 months. There is no minimum PSA level required and the maximum PSA must be =50 ng/mL.
4. Is a male patient aged 18 years or older
5. Has an ECOG (Eastern Cooperative Oncology Group) score of =2
6. Has a life expectancy of at least 24 months

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 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.

Study & Design

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