eoadjuvant chemotherapy with Cabazitaxel in high risk prostate cancer patients prior to radical prostatectomy

Phase 1

• Conditions: high-risk prostata cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001062-41-DE
• Lead Sponsor: RWTH Aachen University, represented by the Rector, himself represented by Clinical Trial Center (CTC-A)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 35

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified