Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT03050866
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03050866
Study Brief:
Protocol Section:
NCT03050866