C61
Conditions
Interventions
Group 1: Patients with metastatic, hormone-naive prostate Cancer
The GILUPI CellCollector® is used to isolate CTCs in vivo. In short, an intravenous catheter (20 gauge, BD Venflon) will be placed int
Sponsors
Klinik für Urologie Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Template of written consent of the patient after patient information - Age = 18 years Prostate Cancer Group: Histologically proven adenocarcinoma of the prostate, Proven metastasis, ECOG 0-1 at the time of screening and Patients for whom a therapy decision is pending Patients with metastatic, hormone-naive PCa OR Patients with metastatic, castration-resistant asymptomatic (low-volume <4 bone metastases), testosterone levels in the castration range (= 0.2 ng / ml) PCa OR Patients with metastatic, castration-resistant symptomatic (high-volume = 4 bone metastases), testosterone level in the castration range (= 0.2 ng / ml) PCa Basic imaging MRI and / or CT and / or whole body scintigraphy up to 3 months before inclusion Control group BPH patients: Histologically confirmed benign prostatic hyperplasia
Exclusion criteria
Exclusion criteria: - Any accompanying circumstances that make a study participation not desirable for the test person - No written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of the AR-V7 splice variant in circulating tumor cells at mRNA level in patients with metastatic castration-resistant prostate cancer. The AR-V7 splice variant should be demonstrated within the 12-month study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of AR-V7 status in CTCs under therapy 2. Comparison of the therapy response of AR-V7 positive and negative patients. Response to therapy is defined as a 50% reduction in PSA compared to baseline PSA 3. Comparison of clinical progression in patients with negative and positive CTC status. (A clinical progression is defined by: diagnosis of new bone or soft tissue metastases detected by imaging procedures -> CT / MRI / whole body scintigraphy and/or Increase of PSA value at three consecutive one-week intervalls, three increases must be 50% above nadir, and PSA> 2 ng / mL 4. Molecular characterization of the CTCs and the tissue with regard to the following markers: PSA, AR (WT or AR-V7) | — |
Countries
Germany
Contacts
Public ContactChristian Göllert
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg Universitätsklinik und Poliklinik für Urologie
Outcome results
None listed