Efficacy of the Acino goserelin 3.6 mg implant that is administered twice in two months in patients with prostate cancer and examination of goserelin and hormone levels in the blood after administration of the Acino goserelin 3.6 mg implant and the Zoladex® 3.6 mg implant in a smaller subgroup of patients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 145

Inclusion Criteria

1. Males between 18 and 89 years of age at the start and for the duration of the study
2. Diagnosis of locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy
3. Testosterone values at Screening (>1.5 ng/mL)
4. Life expectancy of at least 6 months
5. Written informed consent

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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 109

Exclusion Criteria

1. Hypersensitivity to Zoladex or to other gonadotropin releasing hormone (GnRH) analogs
2. Concomitant treatment with any GnRH analogs. Patients who previously underwent an intermittent treatment scheme may be included if no more than 2 treatment cycles were received. A treatment cycle is
defined as the continuous and repeated administration of a GnRH analog (according to the prescribing information) until a discontinuation of treatment based on the patient's physical and / or disease status as
judged by the investigator. The re-initiation of a subsequent GnRH analog administration (based on medical judgement) after the treatment discontinuation is defined as the start of a new treatment cycle.
3. Considered for curative therapy i.e. radical prostatectomy or radiotherapy within 2 months from inclusion
4. Cancer diagnosis within the last 5 years except prostate cancer, low grade bladder cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
5. Clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or other condition including alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator (using the ECOG [Eastern Cooperative Oncology Group] performance scale; patients who have an ECOG performance status of =3 will be excluded).
6. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures
7. Previous participation in this study
8. Known allergy against one of the ingredients in the test and reference preparation
9. Having used any investigational medication or medical device in the 12 weeks prior to Screening or scheduled to use another investigational medication or medical device during the study
10. Participation in another clinical study within 30 days before screening
11. Absence of effective contraception (i.e. use of condoms or sexual abstinence)
12. Employee at the investigational site, relative or spouse of the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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