An open label, parallel group, Phase III clinical study in patients with advanced prostate cancer suitable for hormonal manipulation to demonstrate the non-inferiority of a new three-month Novosis Goserelin 10.8 mg implant versus the reference product Zoladex® 10.8 mg and to show the comparability of the Novosis Goserelin 3.6 mg implant applied every 28 days for three months with the new three-month Novosis Goserelin 10.8 mg implant
- Conditions
- prostate cancer suitable for hormonal manipulation
- Registration Number
- EUCTR2006-004587-30-HU
- Lead Sponsor
- OVOSIS AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- 60
Males aged 18 years or older
Confirmed new diagnosis of advanced carcinoma of the prostate suitable for hormonal manipulation
Life expectancy of at least six months
The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form
The patient is able to understand and follow instructions and is able to participate in the study for the entire period
Patients must have given their 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?
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Hypersensitivity to Zoladex® or to other GnRH analogues
Treatment with a drug modifying testosterone level or function is prohibited.
Treatment and/or pretreatment with other GnRH analogues
Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion
Cancer disease within the last 10 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
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
Mental incapacity or language barriers precluding adequate understanding or co-operation
Patients who have received an investigational drug within the last 12 weeks preceding Visit 1
Previous participation in this study
Simultaneous or less than 30 days earlier participation in another clinical trial
Known allergy against one of the ingredients in the test and reference preparation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: <br>To demonstrate that the new Novosis Goserelin 10.8 mg implant is therapeutically equivalent to the Zoladexâ 10.8 mg (ASTRA-ZENECA) and to the Novosis Goserelin 3.6 mg implant applied every 28 days for 3 months (AUA of the testosterone levels on days 28, 42, 56, 70 and 84.;Primary end point(s): ;Secondary Objective: Efficacy:<br>Testosterone levels on Days 28, 42, 56, 70, 84<br>Percentage of patients who have reached castration level of testosterone (2 nmol/l) at the study end (Day 84).<br>Plasma levels of goserelin (days 0, 28, 56, 84).<br>The results of the clinical examination of the prostate including PSA.<br><br>Safety:<br>Description of AEs/SAEs <br>Assessment of tolerability <br>ECG at day 0 and at study end<br>Vital signs at all visits<br>Safety labs prior to implantations and at study end<br><br>
- Secondary Outcome Measures
Name Time Method