Prostate cancer
Conditions
Interventions
Product Name: Zoreline
Pharmaceutical Form: Implant in pre-filled syringe
INN or Proposed INN: Goserelin
Other descriptive name: GOSERELIN ACETATE
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Novalon S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged 18 years (inclusive) or above 2. Histologically confirmed prostate adenocarcinoma and indicated for ADT. This includes but is not limited to subjects suffering from Localized intermediate-risk or high-risk Prostate Cancer (having a clinical state of T2b and =T2c) and subjects with Locally Advanced Prostate Cancer (having T3-4 as clinical state) [Mottet, 2018; NICE Guideline, 2014]. Previous prostatectomy and/or prostate radiotherapy is allowed. 3. Willing to give informed consent in writing 4. Willing and able to attend the scheduled study visits and to comply with the study procedures 5. Testosterone level > 250 ng/dL 6. PSA level = 4 ng/mL Exception: for subjects who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed. 7. Life expectancy > 1 year 8. Body Mass Index between 18.5 and 35.0 kg/m2 inclusive 9. ECOG score of =2 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including gonadotrophin-releasing hormone (GnRH) receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit (with a maximum of 2 previous treatment cycles allowed in case of GnRH analog treatment) 2. Scheduled for prostatectomy or prostate radiotherapy during study period 3. Any subject at risk as per Investigator’s judgement for urinary obstruction or spinal cord compression due to potential testosterone surge 4. Alanine aminotransferase (ALT) or aspartate transaminase (AST) =2x upper limit of normal (ULN) 5. Estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <50 mL/min/1.73m2 at screening visit 6. Has received an investigational drug within the last 28 days before Visit 2 (Cycle 1 Day 1) or longer if considered by the Investigator to possibly influencing the outcome of this study 7. History or presence of any malignancy other than adequately treated squamous cell /basal cell carcinoma of the skin within the last five years 8. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion. A profound risk-benefit assessment should be done when the subject is suffering from diabetes mellitus, osteoporosis or cardiovascular disease because of possible adverse events 9. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study medication 10. Hypersensitivity to GnRH and its analogues 11. Other abnormal laboratory results which in the judgment of the Investigator would affect the subject's health or the outcome of the study 12. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the ability of Zoreline 10.8 mg subcutaneous implant to induce testosterone serum suppression (=50 ng/dL) in male subjects with prostate cancer by Day 29 of Cycle 1 at the latest and have this confirmed at Day 85 of Cycle 1 and Day 85 of Cycle 2 (End of Treatment);Secondary Objective: • To assess general safety and acceptability of the drug and syringe combination in line with standard of care • To characterize the goserelin plasma concentration profile (time to reach Cmax [Tmax], minimum plasma concentration [Cmin], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]) from Day 1 to Day 85 in each treatment cycle, i.e. during two consecutive treatment cycles in which Day 85 represents the end of treatment of each cycle. The area under the curve will be extrapolated to infinity (AUC0-8) and terminal (apparent elimination) half-life (t½) will be determined • To characterize the testosterone serum concentration profile (Cmax, AUC) including initial surge between Day 1 and Day 29 of Cycle 1, time to achieve castration level, acute on chronic phenomenon, surge at re-injection and potential escape (surge) following the onset of suppression after the initial surge ;Primary end point(s): The ability of Zoreline 10.8 mg subcutaneous implant to induce testosterone serum suppression (=50 ng/dL) in male subjects with prostate cancer by Day 29 of Cycle 1 at the latest and have this confirmed at Day 85 of Cycle 1 and Day 85 of Cycle 2 (End of Treatment);Timepoint(s) of evaluation of this end point: Day 29 of Cycle 1, Day 85 of Cycle 1 and Day 85 of Cycle 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamics: • Serum concentrations of testosterone including initial surge between Day 1 and Day 29 of Cycle 1, time to achieve castrate level, acute on chronic phenomenon, surge(s) at re-injection and potential escape (surge) following the onset of suppression after the initial surge in Cycle 1 to Day 85 of Cycle 1 (pre-dose of Cycle 2) and after the surge at re-injection in Cycle 2 to Day 85 of Cycle 2 (End of Treatment) Pharmacokinetics: • Plasma concentrations of goserelin Safety: • Occurrence of serious and non-serious adverse events, including local assessment of the injection site ;Timepoint(s) of evaluation of this end point: Timepoints mentioned in bullet E.5.2 (secondary endpoint) | — |
Countries
Georgia, Germany, Moldova, Republic of, Ukraine
Contacts
Public ContactMonique Muller
SMS-oncology
Outcome results
None listed