prostate cancer MedDRA version: 14.1 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 Leuprorelin 10.72 mg implant
Pharmaceutical Form: Implant
INN or Proposed INN: LEUPRORELIN ACETATE
CAS Number: 74381-53-6
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
AMW GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged 18 years or older 2. Diagnosis of locally advanced, recidivated or metastatic carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention 3. Normal testosterone values (> 8 nmol/L or > 2.3 ng/mL) at screening according to immunoassay 4. Life expectancy of at least six months 5. The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form 6. The patient is able to understand and follow instructions and is able to participate in the study for the entire study period 7. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to leuprorelin or to other GnRH analogues 2. Treatment with GnRH analogues completed less than 6 months prior to the baseline visit 3. Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion 4. Cancer disease within the last 5 years except prostate cancer, and except surgically removed basocellular or squamous cell carcinoma of the skin 5. 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 6. Mental incapacity or language barriers precluding adequate understanding or co-operation 7. Previous participation in this study 8. Simultaneous or less than 12 weeks earlier participation in another clinical trial 9. Known allergy against one of the ingredients in the test preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).;Secondary Objective: The leuprorelin blood levels will be measured as a secondary objective. The clinical efficacy will also be documented by determining PSA, LH and FSH.;Primary end point(s): Primary efficacy variables are the testosterone plasma levels measured by LC-MS/MS at each visit from Day 28 until the end of the study. Efficacy endpoints derived from the primary efficacy variables are: • The percentage of patients with plasma testosterone below castrate level (i.e. below 0.5 ng/mL) 4 weeks after treatment initiation (at Day 28) and at the end of the first treatment cycle (Day 84) • The percentage of patients with plasma testosterone below castrate level (i.e. below 0.5 ng/mL) at the end of the study (Day 168) • The percentage of patients with testosterone levels above castrate level (i.e. above 0.5 ng/mL) at the beginning of the second treatment cycle (i.e. on Day 87) • The percentage of patients with consistent suppression of testosterone levels below castrate level (i.e. below 0.5 ng/mL) at all visits from Day 28 until the end of the study • The percentages of patients with 0, 1, 2, and more than 2 of their testosterone levels measured from Day 28 until the end of the study above castrate level (i.e. above 0.5 ng/mL).;Timepoint(s) of evaluation of this end point: Testosterone plasma levels measured by LC-MS/MS at visits Day 28, 42, 56, 70, 84, 87, 98, 112, 126, 140, 154, 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: 1. Mean values of testosterone, leuprorelin, LH, FSH and PSA levels by visit 2. Time to achieving testosterone plasma levels below castrate level, i.e. first visit with a testosterone plasma level below castrate level (i.e. below 0.5 ng/mL) Safety Variables: • Adverse Events • Vital signs, body weight and temperature • Safety laboratory assessments • Changes between baseline and end of study in findings from the examination of the prostate • Assessment of local tolerability of the implant;Timepoint(s) of evaluation of this end point: Efficacy endpoints: throughout the treatment phase, PSA on Day 0 , Day 84 and Day 168. Adverse events and vital signs: throughout the treatment phase Body weight, temperature, safety laboratory, and local tolerability: Day 0, Day 84, Day 168 Examination of prostate: Day 0 and Day 168. | — |
Countries
Germany
Contacts
Public ContactDepartment of Clinical Research
AMW GmbH
Outcome results
None listed