OPEN LABEL, MULTICENTER STUDY ON PHARMACOKINETICS, PHARMACODYNAMICS, EFFICACY AND SAFETY OF GOSERELIN 10.8 mg IMPLANT HEXAL IN PATIENTS WITH ADVANCED HORMONE DEPENDENT PROSTATE CANCER

• Conditions: Palliative treatment of advanced hormone dependent prostate cancer.; MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2008-004351-29-BG
• Lead Sponsor: HEXAL AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1)Age =18 and =85 years
2)Histologically confirmed diagnosis of advanced hormone dependent adenocarcinoma of the prostate stage T3-4N0M0, T1-4N1M0 or T1-4N0-1M1 and for which a curative treatment by surgery or radiotherapy is not possible
•either as newly diagnosed adenocarcinoma of the prostate
•or recurrence of adenocarcinoma of the prostate after previous prostatectomy and/or radiotherapy and/or brachytherapy
3)Life expectancy > 12 months
4)ECOG Performance status 0-2
5)Testosterone level > 2.3 ng/ml at screening
6)Patients with ability to follow study instructions and likely to attend and complete all required visits
7)Written informed consent of the patient.
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

1)Patients expected to require additional anti-neoplastic treatment during the entire study period
2)Patients with previous hormonal treatment of prostate cancer
3)Patients with previous chemotherapy, antibody therapy, gene therapy, immunmodulating therapy (e.g. somatostatin)
4)Patients with previous orchiectomy and other treatments disturbing the hypothalamic-pituitary-gonadal axis (hypophysectomy, adrenalectomy)
5)Patients at particular risk of spinal cord compression
6)Patients with known hormone-refractory prostate cancer
7)Severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range) and/or renal dysfunction (creatinine > 1.8 mg/dl)
8)History of blood coagulation disease
9)Evidence of any uncontrolled medical illness other than prostate cancer precluding study treatment or patient survival
10)Any other concurrent malignancy except squamous and/or basal cell carcinoma of the skin
11)Primary central nervous system disease with or without brain metastases
12)History of severe drug related allergy
13)Patients with a known allergy to one of the ingredients of the test product
14)Patients who participate simultaneously in another clinical study or who have participated in any clinical study involving an investigational drug within 1 month prior to start of this study with visit 0.
15)Patients with a physical or psychiatric condition which at the investigator’s discretion may put the patient at risk, may confound the study results, or may interfere with the patient’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified