Cabazitaxel in mCRPC Patients With AR-V7 Positive Circulating Tumor Cells (CTCs)

• Status: Active, not recruiting
• Trial end date: 2022-08-19
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: Sanofi
• Treatments: Antiemetics; Histamine; Histamine Antagonists; Histamine H1 Antagonists; Histamine H2 Antagonists

Criteria

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