Locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy MedDRA version: 17.0 Level: LLT Classification code 10007462 Term: Carcinoma prostate System Organ Class: 100000004864
Conditions
Interventions
Product Name: Goserelin 3.6 mg Implant
Pharmaceutical Form: Implant
INN or Proposed INN: Goserelin
CAS Number: 65807-02-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Acino Supply AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males between 18 and 89 years of age at the start and for the duration of the study 2. Diagnosis of locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy 3. Testosterone values of >1.5 ng/mL at Screening (Visit 1) 4. Life expectancy of at least 6 months 5. Written informed consent 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 109
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to Zoladex or to other gonadotropin releasing hormone (GnRH) analogs 2. Previous androgen deprivation therapy, treatment with GnRH analogs, treatment with antiandrogens or androgen receptor blockers is not allowed within 3 months before baseline, except treatment with non-steroidal antiandrogens as described in the protocol. 3. Concomitant treatment with any GnRH analogs. Patients who previously underwent an intermittent treatment scheme may be included if no more than 2 treatment cycles were received. A treatment cycle is defined as the continuous and repeated administration of a GnRH analog (according to the prescribing information) until a discontinuation of treatment based on the patient’s physical and / or disease status as judged by the investigator. The re-initiation of a subsequent GnRH analog administration (based on medical judgement) after the treatment discontinuation is defined as the start of a new treatment cycle. 4. Considered for curative therapy i.e. radical prostatectomy or radiotherapy within 2 months from inclusion 5. Cancer diagnosis within the last 5 years except prostate cancer, low grade bladder cancer, and surgically removed basocellular or squamous cell carcinoma of the skin 6. Uncontrolled cardiac disease, including myocardial infarction within 12 months before screening, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of =3, unstable angina, abnormal blood pressure, severe cardiac arrhythmias, electrolyte abnormalities, congenital long QT syndrome, or cerebrovascular disease including stroke within 3 years of screening. 7. History of abnormal blood pressure, unless adequately controlled with conventional treatment. Normal blood pressure is defined as BP =90/60 mm Hg for those below 80 years of age, or =90/60 mm Hg for those above 80 years of age. NOTE: In case patients present with abnormal BP readings at Visit 1 then they may get treated for hypertension by a doctor, and return for the Visit 2 assessments. If their BP values are found acceptable at Visit 2, they can still be included in the study. 8. Concomitant medication of class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medications as well as bupropion, moxifloxacin, and SSRIs. 9. Uncontrolled diabetes mellitus, or HbA1c>9%, at the time of screening or diabetic complications (retinopathy, neuropathy, nephropathy, PAD) within the past year. 10. Medical history or concurrent condition of psychiatric disorders, such as psychotic disorders and depression. 11. Medical history of seizures, convulsions, epilepsy, central nervous system anomalies, tumors, or anticonvulsive treatment. 12. Medical history or current condition osteoporosis. 13. Condition of ureteric obstruction or spinal cord compression. 14. Previous orchiectomy, adrenalectomy, or hypophysectomy 15. Medical history of any clinically significant neurological, gastrointestinal, renal, hepatic, respiratory, endocrine, hematological, dermatological or infectious disorder or other condition including alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator (using the ECOG [Eastern Cooperative Oncology Group] performance scale; patients who have an ECOG performance status of =3 will be excluded). 16. Mental incapacity or language barriers prec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone. ;Secondary Objective: None;Primary end point(s): Testosterone response rate defined as testosterone values sustained below castration level (0.5 ng/mL) i.e. all testosterone values at and after Day 28 until Day 56 must be < 0.5 ng/mL;Timepoint(s) of evaluation of this end point: At and after Day 28 until Day 56 (Days 28, 31, 35, 42, 49 and 56) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: E1 - Percentage of patients who have reached castration level of testosterone (<0.5 ng/mL) at the last visit (Day 56) E2 - Time course of testosterone levels on Days 28, 31, 35, 42, 49, 56 E3 - Time after first implantation until castration level of testosterone is achieved E4 - Rate of patients with testosterone values sustained below 0.2 ng/mL at and after Day 28 until Day 56 E5 - Results of clinical examination of the prostate E6 - Prostate-specific antigen (PSA) level Pharmacokinetics and luteinizing hormone/folligcle stimulating hormone (LH/FSH): P1 - Plasma levels of goserelin, luteinizing hormone/follicle stimulating hormone (LH/FSH) between Day 0 (first implantation) and Day 56 (last visit) Safety and tolerability: S1 - Adverse events S2 - Electrocardiogram (ECG) at the day of implantation, prior to implantation, and at study end S3 - Safety laboratory (including glucose and HbA1c) S4 - Vital signs, and body weight S5 - Local Tolerability ;Timepoint(s) of evaluation of this end point: Efficacy: E1 - Day 56 E2 - Days 28, 31, 35, 42, 49, 56 E3 - Day at which castration level of testosterone is achieved E4 - At and after Day 28 until Day 56 (Days 28, 31, 35, 42, 49 and 56) E5 - Day 56 E6 - Days 28, 31, 35, 42, 49, 56 Pharmacokinetics and luteinizing hormone/follicle stimulating hormone (LH/FSH): P1 - Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56 Safety and tolerability: S1 - Informed consent until all follow-ups have been concluded after the end of the study S2 - Day 56 S3 - Safety laboratory: Days 14, 28, 56; Glucose: Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56; HbA1c: Day 56 S4 - Vital signs: Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56; body weight: Day 28, Day 56 S5 - Days 1, 7, 28, 35, 56 | — |
Countries
Czech Republic, Germany, Poland
Contacts
Public ContactProject Management
FGK Clinical Research GmbH
Outcome results
None listed