An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (ACINO Goserelin 10.8 mg Implant) applied every 84 days for 168 days - C_30060_P3_03

Conditions: prostate cancer
MedDRA version: 12.0Level: LLTClassification code 10060862Term: Prostate cancer

Registration Number: EUCTR2009-016200-23-DE

Lead Sponsor: Acino Supply AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Males aged 18 years or older
Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention
Normal testosterone values (> 3ng/mL) at screening and baseline visit
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? 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to Zoladex? or to other GnRH analogues
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 preparation.