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

Conditions: ADVANCED PROSTATE CANCER

Registration Number: EUCTR2005-005742-39-LT

Lead Sponsor: Ardana Bioscience Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- Histologically proven adenocarcinoma of the prostate
- Androgen deprivation therapy suitable (advanced prostate cancer i.e. with local invasion or/and 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
- 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the duration of action of an initial loading dose regimen of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml);Secondary Objective: - To assess the pharmacodynamics of teverelix in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5 ng/ml) until (after week 3) 2 consecutive, increasing T levels above castration level with the latter one above 2 ng/ml, have been recorded<br>- To assess the effects on Luteinizing Hormone (LH)<br>- To assess the effects on Prostate Specific Antigen (PSA)<br>- To assess the safety of Teverelix LA in terms of :<br>- Local tolerability and <br>- Systemic tolerability (adverse events and changes in laboratory parameters);Primary end point(s): Suppression of testosterone to castrate level (0.5 ng/ml)

Secondary Outcome Measures