A Phase II multi-centre, open-label study investigating the long-term safety and efficacy of Teverelix, long-acting formulation in patients with advanced prostate cancer – follow on study to Study N°. ARD-0301-004

• Conditions: ocally advanced and/or metastatic prostate cancer; MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2007-004349-13-LT
• Lead Sponsor: Ardana Bioscience Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

•Per protocol completion of study no. ARD-0301-004
•Prostate cancer assessed by the clinical investigator as being adequately controlled by 4-weekly subcutaneous administration of 90 mg Teverelix LA
•Suitable androgen deprivation therapy (advanced prostate cancer i.e. with local invasion and/or metastasis)
•Signed, written informed consent

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

•Testosterone > 2 ng/ml at Week 24 visit of ARD-0301-004 study
•Increasing PSA levels at Week 24 visit of ARD-0301-004 study
•Liver or renal function tests (ASAT/SGOT, ALAT/SGPT), total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis.
•Any contraindication to the use of Teverelix LA
•Life expectancy of less than 1 year
•Bilateral orchidectomy
•Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug
•Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance
•Evidence of concurrent malignancy
•Exposure to another investigational agent, other than Teverelix LA, within the last month
•Lack of ability or willingness to give informed consent
•Anticipated non-availability for study visits/procedures

Study & Design

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