metastatic castration-resistant prostate cancer cabazitaxel response
Conditions
Interventions
Cabazitaxel (administered in context of standard clinical practice)
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. ≥18 years of age 2. Signed informed consent according to ICH-GCP before start of treatment and any study specific procedures 3. ECOG Performance Status 0-2 4. Histological or cytological confirmation of adenocarcinoma of the prostate. 5. Evidence of locally advanced disease, bone-, visceral and/or lymph node metastases on bone scan, CT-scan or MRI 6. Continued androgen deprivation therapy either by orchidectomy or GnRH agonist/antagonist 7. Serum testosterone level < 1.7 nmol/L (<50 ng/mL) within 21 days before treatment start 8. Disease progression occurring during or after completion of docetaxel treatment (+ADT) in hormone-sensitive setting or during or after completion of docetaxel treatment (as 1st line) in castration-resistant setting. Patients should have received adequate exposure to docetaxel, that is, not inferior to a cumulative dose of 225 mg/m². Disease progression to be defined as either (1) radiologic disease progression of osseous disease and/or of measurable lesions according to the Prostate Cancer Working Group 2 (PCWG2) criteria and/or (2) prostate-specific antigen progression according to the PCWG2 criteria and disease-related worsening of pain as judged by the treating physician. 9. Treatment with curative intent is not an option and patient has an indication for cabazitaxel as judged by the medical care provider.
Exclusion criteria
Exclusion criteria: 1. Impossibility or unwillingness to take oral drugs 2. Geographical, psychological or other non-medical conditions interfering with follow-up 3. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus or active systemic or local bacterial, viral, fungal - or yeast infection) 4. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent 5. Chemotherapy or immunotherapy (other than LHRH analogues) within the last 4 weeks before study inclusion 6. Prior treatment with cabazitaxel, abiraterone, enzalutamide or radium-223 post-docetaxel. 7. History of severe hypersensitivity reaction (≥grade 3) to docetaxel 8. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs. 9. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) 10. Patients who have a concurrent yellow fever vaccination 11. Abnormal liver functions consisting of any of the following (within 21 days before start of treatment): • Total bilirubin > 1 x ULN (except for patients with documented Gilbert’s disease); • Alanine aminotransferase (ALAT/SGPT) and/or aspartate aminotransferase (ASAT/ALAT) > 1.5 x ULN 12. Abnormal hematological blood counts consisting of any of the following (within 21 days before start of treatment): • Absolute neutrophil count < 1.5 x 109/L • Platelets < 100 x 109/L • Hemoglobin < 6.2 mmol/L (< 10.0 g/dL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to assess the predictive value of FCH uptake changes as defined with FCH-PET after one cycle of treatment (vs. baseline). This, in order to predict the clinical response, as defined by PCWG2 criteria, to treatment of mCRPC with cabazitaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to assess the predictive value of alternative PET measures, the interlesional concordance and the use of a single-lesion versus a multiple-lesion approach. | — |
Contacts
Public ContactD.E. Oprea-Lager
Department of Nuclear medicine and PET research de Boelelaan 1117 PO Box 7057
Outcome results
None listed