Clinical trial NCT01941550: Neoadjuvant Chemotherapy With Cabazitaxel
Official title: Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: High-Risk Cancer
Keywords: untreated, high risk prostate cancer
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Complete pathological response rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
state: Nordrhein-Westfalen
Study officials:
References: