An Open-Label, Randomised, Multi-Centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients with Prostate Cancer Treated for 12 Months / FE 200486 CS12

Phase 2

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00000024
• Lead Sponsor: Endocrine OncologyFerring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Histological confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This inc1udes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.
Male patient aged 18 years or over.
Has a baseline testosterone above the lower limit ofnorma1 range.
Has an ECOG (Eastern Co-operative Oncology Group) score of 2 (see Appendix II).
Has a PSA value of 2ng/mL.
Has a life expectancy of at least 6 months.

Exclusion Criteria

Any patient meeting one or more of the following exc1usion criteria will not be entered into the study:
Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to Screening Visit.
Currently or recently (within the last 12 weeks preceding Screening Visit) under treatment with any ether drug modifying the testosterone level or function (please see examples listed in Appendix III).
Is considered to be candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
Has a history of severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, angioderma, angioneurotic oedema or Quincke Oedema.
Has hypersensitivity towards any component 0 f the investigational products (degarelix or mannitol).
Has history of ether cancer within the last 5 years except from prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
Has elevated serum ALT level more than three times above tipper level of normal range or serum total bilirubin level above all and a half above tipper level of normal range as measured by the laboratory at the Screening Visit.
Has a known hepatic disease.
Has either clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient`s participation in this study or evaluation of study results.
Has a clinically significant disorder or any ether condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion ofthe study as judged by the investigator. Patients with symptomatic prostate cancer may participate in the study
Has a mental incapacity or language precluding adequate understanding or co-operation.
Has received an investigational drug within the last 12 weeks preceding Screening Visit.
Has previously participated in any degarelix study.

Study & Design

• Study Type: interventional
• Study Design: Not specified