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-LV

Lead Sponsor: Ardana Bioscience Ltd

Brief Summary: Not available

Detailed Description: Not available

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
•Baseline Testosterone value below 2.31 ng/ml
•Bilateral orchidectomy
•Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety of Teverelix LA in terms of local and systemic tolerability (adverse events and changes in laboratory parameters);Secondary Objective: •To assess the long-term efficacy of Teverelix LA in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml) up to 32 weeks<br>•To assess the effects on Prostate Specific Antigen (PSA)<br>•To assess the effects on Luteinizing Hormone (LH)<br>;Primary end point(s): maintenance of castration (testosterone < 0.5 ng/ml) until Week 28

Secondary Outcome Measures