Clinical trial · Interventional
Cabazitaxel in mCRPC Patients With AR-V7 Positive Circulating Tumor Cells (CTCs)
A Single Arm Phase 2 Multicenter Study Determining the Response to Cabazitaxel in Metastatic Prostate Cancer (mCRPC) Patients With AR-V7 Positive Circulating Tumor Cells (CTCs)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiemetic | Other | — | UNRESOLVED |
| Antihistamine | Other | — | UNRESOLVED |
| Cabazitaxel | Drug | Cabazitaxel | ALIAS |
| Corticosteroid | Other | — | UNRESOLVED |
| H2 antagonist | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- Treatment intervention with Cabazitaxel with premedication as necessary (antihistamine, corticosteroid, H2 antagonist, antiemetic prophylaxis)
- interventionNames
- Drug: Cabazitaxel
- Other: Antihistamine
- Other: Corticosteroid
- Other: H2 antagonist
- Other: Antiemetic
Primary outcomes (1)
- measure
- PSA response
- timeFrame
- 12 weeks after start of treatment
- description
- The primary endpoint is PSA response, defined as a ≥50% PSA decline from baseline during therapy.
Secondary outcomes (10)
- measure
- CTC response
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available