Prospektive randomisierte Phase II Studie zur Behandlung von Patienten mit fortgeschrittenem hormonrefraktären Prostatakarzinom mittels LHRH-Analoga und Somatostatin-Analoga unter Berücksichtigung der neuroendokrinen Expression sowie des Androgenrezeptorstatus - Soma-47-Studie

• Conditions: Patients with hormone - independent non metastatic prostate cancer; MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer

• Registration Number: EUCTR2008-002338-31-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-31
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Patients who have given written informed consent prior to the study
•Patients with biochemical relapse after radical prostatectomy under hormone ablative therapy using an LHRH analogue, or after surgical castration, with no computer tomographic or skeletal scintigraphic evidence of manifest metastatic lesions.
•Serum testosterone < 1.75 nmol/l
•Karnofsky index > 70
•Age >40 /< 90
•No previous or concomitant chemotherapy ( Exception: hormone therapy)
•No concomitant radiotherapy
•Clinical chemistry: essentially normal values for liver, pancreas and kidney function (bilirubin < UNL mg/dl, creatinine < 1.5x UNL mg/ dl, amylase and lipase within normal range)
•No chronic obstructive lung disease or other allergic predisposition from medical history

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

•Karnofsky index < 70
•Patients unwilling to give written informed consent to study participation
•Previous pancreatic illness e.g. pancreatitis
•Alcohol abuse
•Obstructive lung disease or known allergic predisposition
•Presence of an uncured second malignant disease
•Intake of drugs which hinder functioning of the immune system
•Previous chemotherapy
•Concomitant radiotherapy
•Cerebral seizures
•Severe physical or psychological concomitant diseases which could impair the compliance of the patient to study protocol procedures or the evaluation of drug safety, e.g. clinically relevant ascites, cardic insufficieny> NYHA III, clinically relevant ECG anomalies
•Intake of other study medication within 30 days prior to randomisation.

Study & Design

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