- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941550
Neoadjuvant Chemotherapy With Cabazitaxel (CLUBNET)
Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Nordrhein-Westfalen
-
Aachen, Nordrhein-Westfalen, Germany, 52074
- Uniklinik RWTH Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
given in 6 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete pathological response rate
Time Frame: 5 years
|
Primary endpoint: overall or cancer specific survival nor progression-free survival(PFS) in 5 years. Composite measurement. Key-parameters:
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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