Clinical trial · Interventional
Neoadjuvant Chemotherapy With Cabazitaxel
Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy
NCT01941550CI-TRIAL-00023840CLUBNETterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator left the site. Site closed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-Risk Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cabazitaxel chemotherapy
- description
- 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.
- interventionNames
- Drug: Cabazitaxel chemotherapy
Primary outcomes (1)
- measure
- Complete pathological response rate
- timeFrame
- 5 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.