Patients with advanced (locally or metastatic) prostate cancer scheduled to receive an LHRH analogue as androgen deprivation therapy
Conditions
Interventions
Product Name: Pamorelin 11,25mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: triptorelin
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
IPSEN FARMACEUTICA BV
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Provision of written informed consent prior to any study related procedures. 2) Male patients aged 18 years and older 3) Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy. 4) Life expectancy of more than 9 months 5) Documented testosterone levels of = 125 ng/dl measured by any laboratory or on site within the previous 6 months 6) Patient able and willing to comply with the requirements of the protocol. 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: 1) Has a history of hypersensitivity to the studied drug or drugs with a similar chemical structure. 2) Was treated with any other Investigational Medicinal Product within the last 30 days before study entry. 3) Has previously received a GnRH analogue, estrogens or a steroidal anti –androgen within the last year preceding the study. 4) Concomitant anti-coagulation treatment. 5) Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study. 6) Patient with known spinal medullar compression. 7) Has a history of, or known current, problems with alcohol abuse. 8) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level = 50 ng/dl at week 24.;Primary end point(s): Primary Efficacy Variables: Percentage of patients achieving a plasma testosterone level = 50 ng/dl (1,7 nmol/l) measured at week 24 ;Secondary Objective: Overall patient acceptability of SC vs IM injection of Pamorelin® 11,25 mg Overall caregiver acceptability of SC vs IM injection of Pamorelin® 11,25 mg To assess the tolerability and safety of SC and IM injections of Pamorelin® 11,25 mg To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via SC injection as compared to Pamorelin® 11,25 mg administered via standard IM injection based on the percentage of patients presenting a testosterone level = 50 ng/dl at week 12 | — |
Countries
Netherlands
Outcome results
None listed