Metastatic castration-resistant prostate cancer. MedDRA version: 19.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]-Fluorocholine
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: 18F-FLUOROMETHYLCHOLINE
Current Sponsor code: 18F-FLUOROMETHYLCHOLINE
Concentration unit: MBq/
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
Male
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 =65 years) yes F.1.3.1 Number of subjects for this age range 15
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 |
|---|---|
| Main Objective: The primary objective of this study is to determine the diagnostic accuracy of the primary PET measure, to predict clinical response in patients with mCRPC treated with cabazitaxel. ;Secondary Objective: 1) To determine the predictive value of alternative quantitative PET measures, including alternative standardized uptake values (SUV), metabolic volume, single lesion versus multiple lesion approach and interlesional concordance (heterogeneity) of PET signal changes. 2) To describe the toxic effects of cabazitaxel in terms of serious adverse events (with reference to CTCAE 4.03 criteria) irrespective of treatment relationship, of as well as cumulative administered cabazitaxel dose. ;Primary end point(s): The main endpoint of this study is the diagnostic accuracy of the PET measures (as defined by PERCIST, using SUVidif with peak VOI) to predict clinical response at 3 and 6 months of treatment respectively, described as sensitivity, specificity, positive and negative predictive values, respectively. ;Timepoint(s) of evaluation of this end point: After 3 and 6 cycles after the start of cabazitaxel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this study are: - predictive value of changes of o alternative standardized uptake values (as described by Verwer et al. [11]) o choline avid tumour volume (volume of lesion, defined using PET-based VOIs [17]) - impact of lesion selection on predictive value o single lesion versus multiple lesion approach (according to PERCIST [7]) - interlesional concordance (heterogeneity) of PET signal changes - serious adverse events (with reference to CTCAE 4.03 criteria) irrespective of treatment relationship - cumulative administered dose of cabazitaxel ;Timepoint(s) of evaluation of this end point: After 3 and 6 cycles after the start of cabazitaxel. | — |
Countries
Netherlands
Contacts
Public ContactAJM van den Eertwegh
VU University Medical Center
Outcome results
None listed