Locally advanced and/or metastatic prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Teverelix LA
Product Code: ARD-03
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Teverelix trifluoroacetate
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Ardana Bioscience Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 •To assess the effects on Prostate Specific Antigen (PSA) •To assess the effects on Luteinizing Hormone (LH) ;Primary end point(s): maintenance of castration (testosterone < 0.5 ng/ml) until Week 28 | — |
Countries
Latvia, Lithuania
Outcome results
None listed