Palliative treatment of advanced prostatic cancer
Conditions
Interventions
Product Name: Buserelin 3M Implant Hexal
Pharmaceutical Form: Implant
INN or Proposed INN: Buserelin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9.45-
Trade Na
Sponsors
HEXAL AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with histologically confirmed advanced adenocarcinoma of the prostate, stage T3-4N0M0, T1-4N1M0 or T1-4N0-1M1 either as newly (within the past 6 weeks) diagnosed adenocarcinoma of the prostate or recurrence of adenocarcinoma of the prostate after previous prostatectomy and/or radiotherapy and/or brachytherapy will be included 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) Patients expected to require additional anti-neoplastic treatment during the entire study period 2) Patients after ureteral/urethral obstruction or at particular risk of developing such obstructions and/or spinal cord compression 3) Patients with known hormone-refractory prostatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of pharmacodynamics, pharmacokinetics, in terms of testosterone suppression and plasma levels of buserelin after Buserelin 3M Implant HEXAL application;Secondary Objective: Efficacy in terms of testosterone levels; pharmakokinetic profiles of buserelin over 6 hours; safety ;Primary end point(s): Proportion of patients with a testosterone level of less than 0.5 ng/ml until week 12 | — |
Countries
Czech Republic
Outcome results
None listed