Randomised, phase III multicenter, open study of lanreotide in non metastatic castration-resistant prostate cancer patients presenting elevated Chromogranin A levels - Poseidon

IPSE0 个研究点开始时间: 2010年12月22日最近更新: 2013年7月15日

适应症

试验速览

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•Age equal to or greater than 18. Histologically proven diagnosis of prostate cancer. Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteininzing hormone releasing hormone agonists (LHRH-a). Chromogranin A elevation above normal range (cut off levels will be > 20 U/L for ELISA assay and > 100 ng/ml for IRMA assay). ECOG Performance Status 0-1 Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to the start of the study treatment: Hb > 9.0 g/dl, absolute neutrophil count (ANC) > 1.500/mm3, platelet count >100.000/ml, total bilirubin < 1.5 times the upper limit of normal (ULN), AST and ALT < 2.5 x ULN (< 5 x ULN for patients with liver involvement of their cancer), serum creatinine < 1 x ULN Life expectancy of at least 6 months. 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with radiological signs of metastatic disease. Patients who according to the investigator opinion are candidate to be treated immediately with chemotherapy (e.g. docetaxel). Patients previously treated with total androgen ablation. Patients eligible to steroidal anti androgens. Diastolic blood pressure >100 mm/Hg despite anti-hypertensive drugs. Clinically significant cardiovascular disease (e.g. cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication). Renal impairment (creatinine levels above NL).Severe Parkinson disease. Known history of atrophic gastritis. Known history of cholelithiasis. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma effectively treated. Previous or concomitant treatment with a somatostatin analogue. Patients with known allergy to any of the components of the study medication.Concomitant assumption of drugs able to interfere with CgA synthesis. Treatment with any investigational drug within 30 days prior to enrolment.

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