Neoadjuvant Chemotherapy With Cabazitaxel

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University

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 <2.5 x ULN;

• Total bilirubin <1.0 x 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