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Neoadjuvant Chemotherapy With Cabazitaxel (CLUBNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01941550
Recruitment Status : Terminated (Investigator left the site. Site closed.)
First Posted : September 13, 2013
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
High-Risk Cancer Drug: Cabazitaxel chemotherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy
Study Start Date : July 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arm Intervention/treatment
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.

Drug: Cabazitaxel chemotherapy
given in 6 cycles
Other Name: Jevtana L01CD04




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941550


Locations
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Germany
Uniklinik RWTH Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01941550    
Other Study ID Numbers: 13-005
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by RWTH Aachen University:
untreated, high risk prostate cancer