Neoadjuvant Chemotherapy With Cabazitaxel (CLUBNET)
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|ClinicalTrials.gov Identifier: NCT01941550|
Recruitment Status : Terminated (Investigator left the site. Site closed.)
First Posted : September 13, 2013
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|High-Risk Cancer||Drug: Cabazitaxel chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Complete pathohistological remission
- Intra/perioperative compl.
- 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
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
|Uniklinik RWTH Aachen|
|Aachen, Nordrhein-Westfalen, Germany, 52074|