Trial document





This trial has been registered retrospectively.
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  DRKS00005269

Trial Description

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Title

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

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Trial Acronym

ClubNet-CABAZ

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URL of the Trial

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Brief Summary in Lay Language

A primary chemotherapy with cabazitaxel before radical prostatectomy should limiting the tumor and a better remove will be possible. At the same time existing metastasis of the tumor will be treated

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Brief Summary in Scientific Language

Cabazitaxel is for treament after radical prostatectomy by progress after docetaxel-chemotherapy in castrate resistant stage approved. The goal of the study is to find out if a chemotherapy with cabazitaxel before radical prostatectomy is beneficial in progression of therapy

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005269
  •   2014/02/19
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  •   yes
  •   Approved
  •   112/13, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  •   2013-001062-41 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Cabazitaxel (Jevtana), 25mg/m2, every three weeks
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   Yes
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Primary Outcome

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.

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Secondary Outcome

• intra- and perioperative complications
• Overall progression-free survival (PFS)
• Metastasis-free survival
• Biochemical, radiological, clinical PFS and androgen-deprivation free survival
• Objective progression during cabazitaxel therapy and after surgery
• PSA response at the end of cabazitaxel therapy
• PSA progression after 12 weeks of cabazitaxel therapy
• Percentage of patients with undetectable PSA (<0.1 ng/ml) after surgery
• Relationship between PSA kinetics, histological response and MRI response
• role of pathohistological parameters such as intraductal, cribriform groth patterns and their 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 mitochondrial DNA
• Toxicity (cabazitaxel associated adverse reactions) will be recorded using the NCI-CTCAE (v4.3), evaluation of surgery related complications according to the Clavien classification.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/26
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Sanof Aventis Group, Paris
    • 75008  Paris
    • France
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    • Uniklinik Aachen - RWTH Aachen, Klinik für Urologie
    • Mr.  Prof. Dr. med.  Axel  Heidenreich 
    • Pauwelsstr. 300
    • 52074  Aachen
    • Germany
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    • Uniklinik Aachen - RWTH Aachen, Klinik für Urologie
    • Ms.  Katja  Jünemann 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi Aventis Group
    • 75008  Paris
    • France
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.