C61
Conditions
Interventions
Group 1: In 50 patients who receive Docetaxel 75 mg/m2 (3 weekly) or 35 mg/m2 (weekly) before the start of the chemotherapy, before cycle III. (75 mg/m2) and before cycle VI. (75 mg/m2) or at correspo
Sponsors
Universitätsmedizin Göttingen, Klinik für Urologie
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Guideline conform planned treatment with Docetaxel or Cabazitaxel in castration resistant prostatate cancer
Exclusion criteria
Exclusion criteria: - secondary malignancy under therapy within the past 5 years (not included low grade bladder cancer) - neuroendocrine tumour in the past medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Are the serum levels of the NE markers (CgA, NSE, ProGRP) significantly (30 % up or down) influenced by Docetaxel/Cabazitaxel chemotherapy (measured before the therapy, before the 3rd and before 6th cycle) compared to the pretherapeutic levels? The PSA is measured the day it arrives (one day after bood withdrawal) in the reference laboratory (Synlab, Leinfelden) by the Siemens-system Centaur (method: LIA). The sample is frozen afterwards until the study is closed. All neuroendocrine markers are analysed after closure of the study by ELISA (company IBL) to reduce technical biases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Does the pretherapeutic level of the marker, the decline or the increase during Docetaxel/Cabazitaxel therapy correlate with biochemical response and time to progression? What are the best factors to predict the biochemical response/ time to progression for Docetaxel/Cabazitaxel? Do the pretherapeutic neuroendocrine markers serve as a prognostic marker for disease specific survival? What parameters influence the pretherapeutic levels of neuroendocrine circulating markers? A biochemical response (for patients with a baseline PSA level of at least 20 ng per milliliter) is defined as a reduction from baseline of at least 50 percent that was maintained for at least three weeks, whereas PSA progression was defined as an increase from the nadir of either at least 25 percent for men with no PSA response or at least 50 percent for all others. The duration of the PSA response is defined as the time between the first and the last evaluations at which the response criteria were met. | — |
Countries
Germany
Contacts
Public ContactJost von Hardenberg
Universitätsmedizin Mannheim, Klinik für Urologie
Outcome results
None listed