A Phase II multi-centre, randomized, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of two loading dose regimens of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as three doses of 120 mg or 180 mg (given as 2 injections of 60 mg or 90 mg on Day 1, repeated on Days 2 & 3) in patients with advanced prostate cancer

• Conditions: ocally advanced and/or metatstatic prostate cancer; MedDRA version: 8.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2006-004572-13-LV
• Lead Sponsor: Ardana Bioscience Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

•Histologically proven adenocarcinoma of the prostate
•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

•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
•Screening QTc interval of = 430 msec
•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
•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 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