Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 5:30 PM
Study NCT ID:
NCT01941550
Status:
TERMINATED
Last Update Posted:
2016-09-13
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy With Cabazitaxel
Sponsor:
RWTH Aachen University
Organization:
Study Overview
Official Title:
Neoadjuvant Chemotherapy With Cabazitaxel in High Risk Prostate Cancer Patients Prior to Radical Prostatectomy
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left the site. Site closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLUBNET
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: