This study is aimed at evaluating the efficacy regarding the response rate and metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high risk prostate cancer.
Patients will be treated by 6 cycles of Cabazitaxel 25 mg/m2 every three weeks and extended radical prostatectomy and extended pelvic lymphadenectomy 4 weeks after completion of chemotherapy. Multiparametric MRI will be performed at baseline, after 3 cycles and after 6 cycles. If there will be evidence of clinical progression after 3rd cycle, patients can be removed from the study and given local therapy, including radical prostatectomy or external beam radiotherapy, at the discretion of the patient's physicians. If patients have evidence of response, they continue on treatment for a total of 6 cycles. If multiparametric MRI demonstrates stable disease an individual risk-benefit analysis has to be performed with regard to continuing or to stopping the neoadjuvant treatment since the definition stable disease includes patients with ≤ 20% tumour shrinkage or tumour progression
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
given in 6 cycles
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Complete pathological response rate
Primary endpoint: overall or cancer specific survival nor progression-free survival(PFS) in 5 years. Composite measurement. Key-parameters: * Complete pathohistological remission * Intra/perioperative compl. * PFS * Metastasis-FS * Biochemical, radiological, clinical PFS and androgen-deprivation FS * Objective progr. during cabazitaxel therapy (cab.th.) and post surgery * PSA response at the end of cab.th. * PSA progression after 12 w. of cab.th. * Percentage of pat. with undetectable PSA (\<0.1 ng/ml) post surgery * Relationship between PSA kinetics, histol. response and MRI response * Role of pathohistol. parameters such as intraductal, cribriform growth patterns and 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 mDNA
Time frame: 5 years
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