prostate cancer MedDRA version: 18.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AMW goserelin 3.6 mg implant
Pharmaceutical Form: Implant
INN or Proposed INN: goserelin acetate
CAS Number: 145781-92-6
Other descriptive name: GOSERELIN ACETATE
Concentration unit: mg
Sponsors
AMW GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Males aged 18 years or older • Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising prostate-specific antigen (PSA) after having undergone surgery or radiotherapy with curative intention • Normal testosterone value (> 10.4 nmol/l or > 3 ng/ml) at screening, according to immunoassay • Life expectancy of at least six months • The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form • The patient is able to understand and follow instructions and is able to participate in the study for the entire study period • Patient has given his written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures. 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 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Hypersensitivity to Zoladex (registered trademark) or to other GnRH analogues • Treatment with GnRH analogues, completed less than 6 months prior to the baseline visit • Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion • Cancer disease within the last 5 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin • Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator • Mental incapacity or language barriers precluding adequate understanding or co-operation • Previous participation in this study • Simultaneous or less than 12 weeks earlier participation in another clinical trial • Known allergy against one of the ingredients in the test preparation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the efficacy of goserelin 3.6 mg implant (when applied every 28 days for 56 days) in suppression of testosterone levels below castrate level (0.5 ng/ml). The study will be considered a successful bridging study, if the response rate, i.e., the percentage of patients with plasma testosterone levels below castrate level (0.5 ng/ml) on Days 28 and 56 (at Visits 4 and 6), will be at least 90% in the patients of the modified full analysis set (see Primary efficacy endpoint). • To demonstrate correct functionality of the application system, as assessed by an increase of plasma goserelin levels to a value above the Lower Limit of Quantification (LLOQ) (i.e., presence of goserelin in plasma) and as assessed by the investigator with confirmation by a witness. ;Secondary Objective: No secondary objectives defined. ;Primary end point(s): Primary efficacy endpoint: The response rate, defined as the percentage of patients with plasma testosterone levels below castrate level (0.5 ng/ml) at the end of the first treatment cycle (Visit 4, Day 28) and at the end of the second treatment cycle (Visit 6, Day 56);Timepoint(s) of evaluation of this end point: Testosterone plasma levels measured by LC-MS/MS at visits day 28 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints: Timepoints of evaluation are included in the above definitions (see E.5.2) Secondary Safety Endpoints: Clinical Examination of the prostate: day 56 Adverse Events and vital signs: throughout the treatment phase Body weight and temperature: day 0, 28, 56 Safety laboratory: day 0, 28, 56 Local tolerability: day 0, 28, 56 ;Secondary end point(s): Secondary Efficacy Endpoints: • Percentage of patients with an increase in plasma goserelin levels at Visit 3 (Day 14) and Visit 5 (Day 42) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of applications with correct functionality of the application system, • Percentage of patients with an increase in plasma goserelin at Visit 3 (Day 14) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of patients with an increase in plasma goserelin at Visit 5 (Day 42) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of patients with plasma testosterone below castrate level (0.5 ng/ml) at Visit 4 (Day 28), • Percentage of patients with plasma testosterone below castrate level (0.5 ng/ml) at Visit 6 (Day 56), • Testosterone levels at baseline (Day 0), at Visit 4 (Day 28) and at Visit 6 (Day 56), • Goserelin levels at Visit 3 (Day 14) and at Visit 5 (Day 42) Secondary Safety Endpoints: • Clinical examination (i.e. digital rectal examination) of the prostate • Assessment of safety and tolerability: - Adverse Events - Vital signs (blood pressure, heart rate), body weight and temperature - Safety laboratory assessments - Assessment of local tolerability of the implant. | — |
Countries
Germany
Contacts
Public ContactDepartment of Clinical Research
AMW GmbH
Outcome results
None listed