Palliative treatment of advanced prostatic cancer
Conditions
Interventions
Product Name: Goserelin 3M Implant Hexal
Pharmaceutical Form: Implant
INN or Proposed INN: Goserelin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10.8-
Trade Na
Sponsors
Hexal AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically confirmed diagnosis of 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 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 study period 2) Patients at particular risk of developing ureteral/urethral obstructions and/or spinal cord compression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of pharmacodynamics in terms of testosterone suppression after goserelin application;Secondary Objective: Efficacy in terms of testosterone levels; pharmacokinetic profiles of goserelin over 6 hours; Safety;Primary end point(s): proportion of patients who were successfully suppressed within 8 weeks after administration and whose testosterone levels remained ? 0.5 ng/ml until week 12, except for escapes | — |
Countries
Lithuania
Outcome results
None listed