Prostate cancer (all stages), Benign prostatic hyperplasia (all stages) Cancer Malignant neoplasm of prostate
Conditions
Interventions
The nanodetector will be inserted in all patients from all groups (A, B and C) for 30 min. With this study we want to compare different methods to detect CTCs. Within the groups there are different se
Sponsors
GILUPI GmbH (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Group A 1. Confirmed diagnosis of prostate cancer of any stage 2. Written informed consent of the patient after explanation by the investigator Group B 1. Are patients which must have the diagnosis of any stages of Benign prostatic hyperplasia (BPH). But apart from this diagnosis, the patients are healthy. 2. Written informed consent of the patient after explanation by the investigator Group C: 1. Healthy female probands according to anamnestic and clinical criteria 2. Written informed consent of the patient after explanation by the investigator
Exclusion criteria
Exclusion criteria: For all groups 1. Age > 18 years 2. Known anaphylaxis 3. Auto immunological diseases: Anti-phospholipid antibody syndrome (lupus anticoagulant), Goodpasture's syndrome, lupus erythematosus, relapsing polychondritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, antineutrophilic cytoplasmic antibody (ANCA); Immuno deficiencies: X-linked aggamaglobulinaemia (XLA), severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), selective IgA deficiency 3. Known infection with: Hepatitis A, B and C, human immunodeficiency virus (HIV), herpes simplex virus (HSV), cytomegalovirus (CMV), syphilis, toxoplasmosis, tuberculosis 4. Not allowed concomitant medication: oral anticoagulants (Phenprocoumon, Coumadin), Platelet aggregation inhibitors (clopidogrel, prasugrel, ASS); recurrent thrombosis and pulmonary embolism In addition for: Group A: heart rhythm disturbances, clinically significant hypotension or hypovolemia Group B:diagnosis prostate cancer Group C: pregnancy and lactation, malignant tumour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Positive isolation of circulating tumor cells from peripheral blood of patients with prostate cancer by using the nanodetector (proof of concept) in comparision to patiens with BPH and healthy volonteers 2. Investigation of the specificity of the device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Review of product-application-procedures 2. Comparison of the results with the CellSearch® method 3. Explorative analysis of cancer related cell pathway proteins by using the CEER-Assay (Prometheus Labs) | — |
Countries
Germany
Outcome results
None listed