Patients with hormone - independent non metastatic prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Trade Name: Somatuline Autogel® 60 mg Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LANREOTIDE
CAS Number: 108736352
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 70 • Age >40 /=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Karnofsky index NYHA III, clinically relevant ECG anomalies • Intake of other study medication within 30 days prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to initiate a secondary hormone ablation with somatostatin analogues for patients with hormone-refractory prostate cancer following radical prostatectomy without computer tomographic or skeletal scintigraphic confirmed manifest metastatic lesions. Primary criteria: • PSA Response Assessment of the PSA (Prostate Specific Antigen) -based response (PSA-R) of patients with homone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment. • CgA Response Assessment of the CgA (Chromogranin A) -based response (CgA) of patients with hormone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment. ;Secondary Objective: -Biological effects -chromogranin A (CgA) in serum -Insulin-like growth factor (IGF-1) in serum -Overall survival -Assessment of safety and feasibility of a somatostatin-analogue therapy in patients with prostate cancer. Experimental study aims - Correlation of therapeutic response of a reduction of PSA or CgA with expression of PSA, CgA, AR and NeuroD1 in primary tissue. The aim of this study is to demonstrate the feasibility and safety together with the optimisation of efficacy of the described therapy in patients with biochemical relapse following radical prostatectomy. ;Primary end point(s): • PSA Response Assessment of the PSA (Prostate Specific Antigen) -based response (PSA-R) of patients with homone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment. • CgA Response Assessment of the CgA (Chromogranin A) -based response (CgA) of patients with hormone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment. | — |
Countries
Germany
Outcome results
None listed