NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Erasmus Medical Center
Conditions: Circulating Tumor Cell, Metastatic Prostate Cancer
Interventions: Cabazitaxel, Antihistamine, Corticosteroid, H2 antagonist, Antiemetic
Countries: Netherlands
After failure on docetaxel, which has been the standard first line therapy for patients with metastatic castration-resistant prostate cancer (mCRPC), several treatment options are currently available. In retrospective studies, resistance has been described to two of the treatment options, enzalutamide and abiraterone, when a splice variant of the Androgen Receptor (AR-V7) is present on circulating tumor cells (CTCs). The investigators hypothesize that patients with AR-V7 positive CTCs do have a meaningful response to cabazitaxel.
Sex: MALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * Continued androgen deprivation therapy either by luteinizing hormone-releasing hormone (LHRH) agonists/antagonists or orchiectomy. * Serum testosterone \<50 ng/mL (1.7 nmol/L) within 21 days before prescreening. * Age ≥18 years * Received prior docetaxel, and experienced disease progression during or after treatment with docetaxel. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (appendix A) * Written informed consent according to ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice) before study treatment and any study specific procedures Exclusion Criteria: * Geographical, psychological or other non-medical conditions interfering with follow-up * Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus or active systemic or local bacterial, viral, fungal - or yeast infection) * Symptomatic central nervous system (CNS) metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent. * Chemotherapy or immunotherapy (other than LHRH analogues) within the last 4 weeks before study inclusion. * Prior treatment with cabazitaxel * Treatment with both abiraterone and enzalutamide in the post-docetaxel setting * Radiotherapy to 40% or more of the bone marrow * Known hypersensitivity to corticosteroids * History of severe hypersensitivity reaction (≥grade 3) to docetaxel * History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs * 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) * Concomitant vaccination with yellow fever vaccine * Abnormal liver functions * Abnormal hematological blood counts
- Delft, Netherlands
- Flushing, Netherlands
- Gouda, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Rotterdam, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Tilburg, Netherlands