Neoadjuvant Chemotherapy With Cabazitaxel

NCT ID: NCT01941550

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-01-31

Brief 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.

Detailed Description

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

Conditions

High-Risk Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel chemotherapy

Patients undergo 6 cycles Cabazitaxel chemotherapy. Cabazitaxel suspension is given once per cycle as infusion intravenously, 1 mg/square meter.

For max. 6 times at all.

Group Type: OTHER

Cabazitaxel chemotherapy

Intervention Type: DRUG

given in 6 cycles

Interventions

Cabazitaxel chemotherapy

given in 6 cycles

Intervention Type: DRUG

Other Intervention Names

Jevtana L01CD04

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

13-005

Identifier Type: -

Identifier Source: org_study_id