Neoadjuvant Chemotherapy With Cabazitaxel

High-Risk Cancer Clinical Trial

— CLUBNET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01941550
• Other study ID #: 13-005
• Status: Terminated
• Phase: Phase 2
• First received: July 22, 2013
• Last updated: September 12, 2016
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High-Risk Cancer

Intervention

Drug:
• Cabazitaxel chemotherapy
given in 6 cycles

Locations

Country	Name	City	State
Germany	Uniklinik RWTH Aachen	Aachen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathological response rate	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	5 years	No