Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006362

Trial Description

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Title

Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy

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Trial Acronym

CLUBNET

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00006362
  •   2014/09/03
  •   2013/07/22
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT01941550  (ClinicalTrials.gov)
  •   13-005  (RWTH Aachen University)
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Health Condition or Problem studied

  •   High-Risk Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Cabazitaxel chemotherapy
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- 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:
Complete pathohistological remission
Intra/perioperative compl.
PFS
Metastasis-FS
Biochemical, radiological, clinical PFS and androgen-deprivation FS
Objective progr. during cabazitaxel therapy (cab.th.) and post surgery
PSA response at the end of cab.th.
PSA progression after 12 w. of cab.th.
Percentage of pat. with undetectable PSA (<0.1 ng/ml) post surgery
Relationship between PSA kinetics, histol. response and MRI response
Role of pathohistol. parameters such as intraductal, cribriform growth patterns and 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 mDNA

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2013/07/31
  •   35
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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 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

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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

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Addresses

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    • RWTH Aachen University
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    • Department of Urology
    • Axel Heidenreich, Prof. 
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    •   [---]*
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    • Department of Urology
    • Axel Heidenreich, Prof. 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


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