eoadjuvant Chemotherapy with Cabazitaxel on patients with high risk Prostate Cancer prior to Radical Prostatectomy

Phase 2

Recruiting

Conditions: C61
Malignant neoplasm of prostate

Registration Number: DRKS00005269

Lead Sponsor: Sanof Aventis Group, Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 35

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 äs androgen deprivation therapy, radiation therapy, or chemotherapy
•ECOG performance Status 0-1
•ASA Status 1-2, Charslon comorbidity score 0-1
•No evidence of active infection
•Hemoglobin > 10.0 g/dL
•Absolute neutrophil count >1.5 x 109/L,
•Platelet count >100 x 109/L,
•AST/SGOT and/or ALT/SGPT <1.5 x ULN;
•Total bilirubin<1.0x ULN,
•Serum creatinine <1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded)
•Patient information and signature of informed consent
•Male > 18 years
•Patients of reproductive age must take appropriate contraceptive precautions during and for 6 months after the end of their participation in the study

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
•ASA Status 4

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures