Phase III, open-label, multi-center study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 10.8 mg goserelin subcutaneous implant (Novalon) in male patients with prostate cancer
- Conditions
- 10038597prostate adenocarcinomaprostate cancer
- Registration Number
- NL-OMON42816
- Lead Sponsor
- ovalon S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary variable:<br /><br>Pharmacodynamics:<br /><br>* The primary objective will be considered as achieved if the lower limit of<br /><br>the 2-sided 95% confidence interval (CI) on the responder rate is >=90%. A<br /><br>responder is defined as a subject who reached plasma testosterone levels below<br /><br>the castrate level (<=50 ng/dL) by Day 29 of Cycle 1 at the latest and<br /><br>maintained plasma testosterone levels below the castrate level (<=50 ng/dL)<br /><br>until Day 85 of Cycle 2 (end of treatment).</p><br>
- Secondary Outcome Measures
Name Time Method