A Phase II multi-centre, open-label study investigating the efficacy and safety of a new GnRH antagonist, Teverelix, long-acting formulation in patients with advanced prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004264-31-LV

Enrollment

Registered

2007-02-20

Start date

2007-02-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced and/or metastatic prostate cancer MedDRA version: 8.1 Level: LLT Classification code 10060862 Term: Prostate cancer

Interventions

Product Name: Teverelix LA Product Code: ARD-0301 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Teverelix trifluoroacetate Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of Teverelix LA in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml) up to 28 weeks.;Secondary Objective: • To assess the effects on Prostate Specific Antigen (PSA) • To assess the effects on Luteinizing Hormone (LH) • To assess the safety of Teverelix LA in terms of: o Local tolerability o Systemic tolerability (adverse events and changes in laboratory parameters) ;Primary end point(s): Generation and maintenance of castration (testosterone < 0.5 ng/ml) until Week 28	—

Measure

Time frame

Main Objective: To assess the efficacy of Teverelix LA in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml) up to 28 weeks.;Secondary Objective: • To assess the effects on Prostate Specific Antigen (PSA) • To assess the effects on Luteinizing Hormone (LH) • To assess the safety of Teverelix LA in terms of: o Local tolerability o Systemic tolerability (adverse events and changes in laboratory parameters) ;Primary end point(s): Generation and maintenance of castration (testosterone < 0.5 ng/ml) until Week 28

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Countries

Latvia, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026