Palliative treatment of advanced hormone dependent prostate cancer. MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Goserelin 10.8 mg Implant HEXAL
Pharmaceutical Form: Implant
INN or Proposed INN: GOSERELIN ACETATE
CAS Number: 65807-02-5
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
HEXAL AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age =18 and =85 years 2) Histologically confirmed diagnosis of advanced hormone dependent adenocarcinoma of the prostate stage T3-4N0M0, T1-4N1M0 or T1-4N0-1M1 and for which a curative treatment by surgery or radiotherapy is not possible • either as newly diagnosed adenocarcinoma of the prostate • or recurrence of adenocarcinoma of the prostate after previous prostatectomy and/or radiotherapy and/or brachytherapy 3) Life expectancy > 12 months 4) ECOG Performance status 0-2 5) Testosterone level > 2.3 ng/ml at screening 6) Patients with ability to follow study instructions and likely to attend and complete all required visits 7) Written informed consent of the patient. 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 with previous hormonal treatment of prostate cancer 3) Patients with previous chemotherapy, antibody therapy, gene therapy, immunmodulating therapy (e.g. somatostatin) 4) Patients with previous orchiectomy and other treatments disturbing the hypothalamic-pituitary-gonadal axis (hypophysectomy, adrenalectomy) 5) Patients at particular risk of spinal cord compression 6) Patients with known hormone-refractory prostate cancer 7) Severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range) and/or renal dysfunction (creatinine > 1.8 mg/dl) 8) History of blood coagulation disease 9) Evidence of any uncontrolled medical illness other than prostate cancer precluding study treatment or patient survival 10) Any other concurrent malignancy except squamous and/or basal cell carcinoma of the skin 11) Primary central nervous system disease with or without brain metastases 12) History of severe drug related allergy 13) Patients with a known allergy to one of the ingredients of the test product 14) Patients who participate simultaneously in another clinical study or who have participated in any clinical study involving an investigational drug within 1 month prior to start of this study with visit 0. 15) Patients with a physical or psychiatric condition which at the investigator’s discretion may put the patient at risk, may confound the study results, or may interfere with the patient’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is focused on efficacy in terms of testosterone suppression. As testosterone (T) suppression is a surrogate parameter for the clinical efficacy, the objective of this study is to show sufficient testosterone suppression after application of Goserelin 10.8 mg Implant HEXAL.;Secondary Objective: To assess the • proportion of patients who were successfully suppressed within 8 weeks after administration and whose testosterone levels remained =0.5 ng/ml until week 17, except for escapes • proportion of patients with escapes from testosterone suppression • time to onset of serum testosterone castrate level • weekly testosterone levels • change in serum PSA and PAP levels over time • subjective clinical symptoms attributable to prostate cancer (dysuria, nycturia, bone pain) • clinical prostate status judged by investigator • overall efficacy as judged by the investigator. Safety: To evaluate the • AEs, local reactions, laboratory parameters • need of antiandrogenic medication because of flare symptoms • blood pressure, pulse rate, ECG • overall tolerability by investigator and patient • concomitant medication. PK / PD: To evaluate the • testosterone and goserelin profile within 7 days after application • plasma levels of goserelin and testosterone over time;Primary end point(s): Evaluation of efficacy in terms of testosterone suppression after goserelin application: • Proportion of patients who were successfully suppressed within 8 weeks after administration and whose testosterone levels remained =0.5 ng/ml until week 13, except for escapes for suppression. | — |
Countries
Bulgaria
Outcome results
None listed