Castration resistant bone metastatic prostate cancer MedDRA version: 18.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: cabazitaxel
CAS Number: 183133-96-2
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male patients older than 18 years • Histologically proven adenocarcinoma of the prostate 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 • Serum testosterone levels 4 weeks. • No prior treatment with cabazitaxel • Able to comply with study requirements • Written information delivered to the patient. Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must also have signed an authorization for the release of their protected health information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Histologic variants in the primary tumor (histologic variants other than adenocarcinoma) • Concurrent therapy with other therapeutic or hormonal agent, including androgen receptor antagonists (bicalutamide, flutamide, nilutamide, enzalutamide), any dose of megestrol acetate (Megace), ketoconazole, abiraterone acetate, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), • Active infection or intercurrent illnesses that are not controlled • Prior radiation therapy completed < 4 weeks prior to enrolment • Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery • Structurally unstable bone lesions suggesting impending fracture • Any “currently active” second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active” malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months • Active psychiatric illnesses/social situations that would limit compliance with protocol requirements. • Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study. • Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV) • Known acute or chronic hepatitis B or C • Other investigational therapies (targeted or vaccine) will require a 4 week washout period before treatment initiation • ?nitiation of bisphosphonate or denosumab therapy within 4 weeks prior to first dose of study drug. Patients on stable doses of bisphosphonates or denosumab that show subsequent tumor progression may continue on this medication; however, patients are discouraged to initiate bisphosphonate therapy during the study. • Patients receiving an investigational drug within 4 weeks prior to enrolment • History of severe hypersensitivity reaction (grade =3) to polysorbate 80 containing drugs • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) • 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) • Inadequate organ or bone marrow function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At baseline, on week 9 of treatment (day 1 of cycle 4), at end of study visit (3 or 4 weeks after last drug dose) ;Main Objective: To explore pretreatment tumor microenvironment molecular characteristics and molecular effects of treatment with Cabazitaxel on the tumor microenvironment of patients with mCRPC in correlation with measures of outcome (ie clinical benefit, PSA decline, radiographic response, time to treatment discontinuation), in an effort to identify predictors of response or resistance to therapy; Secondary Objective: • To assess ECOG performance status • To assess PSA response • Radiological progression-free survival (according to PCWG2) • Pain status (using the numerical rating scale from 0 to 10). • Time to best clinical benefit (based on pain, analgesic consumption, and performance status) • Overall survival • Prospective collection of bone marrow biopsies and aspirates to measure the effect of Cabazitaxel on markers of bone metabolism • To explore the potential association between serum PSA with bone marrow androgen levels and androgen receptor expression while on Cabazitaxel • To explore the correlation between levels of circulating androgens and those in the bone marrow before and during treatment with Cabazitaxel with measures of efficacy ;Primary end point(s): To explore molecular effects of treatment with Cabazitaxel on the tumor microenvironment of patients with mCRPC in correlation with measures of outcome (ie clinical benefit, PSA decline, radiographic response, time to treatment discontinuation), in an effort to identify predictors of response or resistance to therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess ECOG performance status 2. To assess PSA response 3. Radiological progression-free survival according to PCWG2 [13] 4. Pain status using a numerical rating scale from 0 to 10. 5. Time to best clinical benefit (based on pain, analgesic consumption, and performance status) 6. Overall survival 7. Prospective collection of bone marrow biopsies and aspirates to measure the effect of Cabazitaxel on markers of bone metabolism 8. Explore the potential association between serum PSA with bone marrow androgen levels and androgen receptor expression while on Cabazitaxel 9. To explore the correlation between levels of circulating androgens and those in the bone marrow before and during treatment with Cabazitaxel with measures of efficacy 10. Safety ; Timepoint(s) of evaluation of this end point: 1. In every cycle 2. In every cycle 3. Imaging assessments at baseline, after cycle 3 and at the end of treatment 4. In evey cycle 5. In every cycle 6. Defined as the time interval from registration to the date of death due to any cause 7. At baseline, before cycle 4 (Day 1) and at end of study visit (or 3-4 weeks after the last cycle) 8. At baseline, before cycle 4 (Day 1) and at end of study visit (or 3-4 weeks after the last cycle) 9. At baseline, before cycle 4 (Day 1) and at end of study visit (or 3-4 weeks after the last cycle) 10. Assessment of Adverse Events will be performed in every cycle | — |
Countries
Greece
Contacts
Public ContactClinical Trials
Hellenic Cooperative Oncology Group
Outcome results
None listed