high-risk prostata cancer patients
Conditions
Interventions
Trade Name: Jevtana 60 mg concentrate and diluent to prepare infusion- suspension
Product Name: Jevtana
Pharmaceutical Form: Concentrate for dispersion for infusion
INN or Proposed INN: Cabazitaxel
CA
Sponsors
RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)
RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Surgically resectable high risk prostate cancer with a 5-year relapse probability = 60% according to the Kattan pre-operative nomogram (cancer 2009, 115: 1005-1010) • no prior therapy for prostate cancer such as androgen deprivation therapy, radiation therapy, or chemotherapy • ECOG performance status 0-1 • No evidence of active infection • Hemoglobin >9.0 g/dL • Absolute neutrophil count >1.5 x 109/L, • Platelet count >100 x 109/L, • AST/SGOT and/or ALT/SGPT =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Evidence of lymph node, visceral or bone metastases • previous major intrapelvic surgery • previous radiation therapy to the small pelvis • any type of malignancies within the last 5 years except basalioma and non-muscle invasive urothelial cancer of the urinary bladder • previous chemotherapy with taxanes (docetaxel, paclitaxel, cabazitaxel) for any indication • Hypersensitivity to the active substance or to any of the excipients • Known or suspected brain metastases or leptomeningeal metastases • Active or symptomatic viral hepatitis or chronic liver disease • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of this trial is to define the pathologic complete response rate of cabazitaxel chemotherapy in patients with untreated, high-risk localized prostate cancer.;Secondary Objective: - intra & perioperative compl. - cabazitaxel associated side effects according NCI-CTC-AE version 4.3 - Overall progression-free survival (PFS) - Metastasis-free surv. - Biochemical, radiological, clinical PFS & androgen-deprivation free survival - Object. progr. during cabazitaxel th. & post surg. - PSA response a.t.end of cabazitaxel th. - PSA progr. after 12 w of cabazit. th. - Percentage of pat.with undetectable PSA (<0.1 ng/ml) after surgery - role of pathohistol. param. such as intraductal, cribriform growth patterns and their effect on response - immunohistochemicl. eval. of prostate biopsy (taken 2 to 6 weeks before surgery) and radical prostatectomy specimens of markers potentially associated with chemoresistance: growth differentiation factor 15, surviving, beta-tubuline I & II & III, p53, bcl-2 - measurement of the serum conc. of free circulating mitochondrial DNA (blood samples will be drawn prior each chemoth. admin., prior to surgery and 1 w after surgery) ;Primary end point(s): The primary endpoint of this trial is to define the pathologic complete response rate of cabazitaxel chemotherapy in patients with untreated, high-risk localized prostate cancer.;Timepoint(s) of evaluation of this end point: 5 years after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • intra- and perioperative complications • Overall progression-free survival (PFS) • Metastasis-free survival • Biochemical, radiological, clinical PFS and androgen-deprivation free survival • Objective progression during cabazitaxel therapy and after surgery • PSA response at the end of cabazitaxel therapy • PSA progression after 12 weeks of cabazitaxel therapy • Percentage of patients with undetectable PSA (<0.1 ng/ml) after surgery • Relationship between PSA kinetics, histological response and MRI response • role of pathohistological parameters such as intraductal, cribriform groth patterns and their effect on response • immunohistochemical evaluation of prostate biopsy and radical prostatectomy specimens of markers potentially associated with chemoresistance: growth differentiation factor 15, surviving, beta-tubuline I & II, p53, bcl-2, • measurement of the serum concentrations of free circulating mitochondrial DNA • Toxicity (cabazitaxel associated adverse reactions) will be recorded using the NCI-CTCAE (v4.3), evaluation of surgery related complications according to the Clavien classification. ;Timepoint(s) of evaluation of this end point: 5 years after treatment | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center
Clinical Trial Center Aachen
Outcome results
None listed