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: Zoreline
Pharmaceutical Form: Implant in pre-filled syringe
INN or Proposed INN: Goserelin
CAS Number: 145781-92-6
Other descriptive name: GOSERELIN ACETATE
Concentration unit: mg milli
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 androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy is allowed. 3. Good physical and mental health as judged by the Investigator determined by medical history, physical examination, clinical laboratory and vital signs 4. Willing to give informed consent in writing 5. Willing and able to attend the scheduled study visits and to comply with the study procedures 6. Baseline testosterone level > 250 ng/dL 7. PSA level = 4 ng/mL Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed. 8. Life expectancy > 1 year 9. Body Mass Index between 18.5 and 35 kg/m2 inclusive 10. 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: 1. Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens) within 6 months prior to the Screening visit 2. Scheduled for prostatectomy or radiotherapy during study period 3. ALT (SGOT) or AST (SGPT) =2x upper limit of normal (ULN) 4. moderate (stage 3B) or severe (stage 4 and 5) chronic kidney disease with an eGFR <45 mL/min/1,73m2 5. Has received an investigational drug within the last 28 days before the screening visit or longer if considered by the Investigator to possibly influencing the outcome of this trial 6. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last five years 7. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion 8. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study drug 9. Other abnormal laboratory results which in the judgment of the Investigator would affect the patient's health or the outcome of the trial 10. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Pharmacodynamics: The primary objective will be considered as achieved if the lower limit of the 2-sided 95% confidence interval (CI) on the responder rate is =90%. A responder is defined as a subject who reached plasma testosterone levels below the castrate level (=50 ng/dL) by Day 29 of Cycle 1 at the latest and maintained plasma testosterone levels below the castrate level (=50 ng/dL) until Day 85 of Cycle 2 (end of treatment). ;Main Objective: The primary objective of the study is to assess the ability of Zoreline 10.8 mg SC implant to induce by Day 29 of Cycle 1 at the latest and maintain up to Day 85 of Cycle 2 (end of treatment) testosterone plasma suppression (=50 ng/dL) in male patients with prostate cancer. ;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 (Tmax, Cmin, Cmax, 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 if possible. •To characterize the testosterone plasma concentration profile (Cmax, AUC) including initial flare between Day 1 and Day 29 of Cycle 1, time to achieve castration level, acute on chronic phenomenon (surge at re-injection between Day 2 and Day 4 of Cycle 2) and potential escape (surge) following the onset of suppression after the initial flare in Cycle 1 to Day 85 of Cycle 1 (pre-dose Day 1 of Cycle 2) and from Day 8 until Day 85 of Cycle 2 (end of treatment). ;Timepoint(s) of evaluation of this end point: Cycle 1 Day 29 and Cycle 2 Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamics: • Plasma concentrations of testosterone including initial flare between Day 1 and Day 29 of Cycle 1, time to achieve castrate level, acute on chronic phenomenon (surge(s) at re-injection) between Day 2 and Day 4 of Cycle 2 and potential escape (surge) following the onset of suppression after the initial flare in Cycle 1 to Day 85 of Cycle 1 (pre-dose of Cycle 2) and from Day 8 until day 85 of Cycle 2 (end of treatment). Pharmacokinetics: • Plasma concentrations of goserelin Safety: • Occurrence of serious and non-serious adverse events.;Timepoint(s) of evaluation of this end point: Blood samples will be taken during screening, on day 1, 2, 4, 8, 15, 29, 36 and 57 of cycle 1 and on day 1, 2, 4, 8, 15, 29, 36, 57 and 85 of cycle 2. Safety: Adverse events will continuously be monitored from signing of informed consent untill the last study related activity. | — |
Countries
Belgium, Germany, Netherlands, Russian Federation
Contacts
Public ContactEveline Verheijen
SMS-oncology
Outcome results
None listed