advanced prostate cancer
Conditions
Interventions
Product Name: Teverelix
Product Code: D84812
EP-24332T
ARD-03
Pharmaceutical Form: Suspension for injection
Sponsors
Ardana Bioscience Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 • 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 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);Primary end point(s): suppression of testosterone to 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 (< 0.5ng/ml) until (after week 3) 2 consecutive, increasing T levels above castration level with the latter one above 2 ng/ml, have been recorded. • to assess the effects on Luteinizing Hormone (LH) • to assess the effects on Prostate Specific Antigen (PSA) • to assess the safety of Teverelix LA in terms of : o local tolerability and o systemic tolerability (adverse events and changes in laboratory parameters) | — |
Countries
Lithuania
Outcome results
None listed