NCT01941550

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

July 22, 2013

Last Update Submit

September 12, 2016

Conditions

High-Risk Cancer

Keywords

untreated, high risk prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cabazitaxel chemotherapy

OTHER

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.

Drug: Cabazitaxel chemotherapy

Interventions

Cabazitaxel chemotherapyDRUG

given in 6 cycles

Also known as: Jevtana L01CD04
Cabazitaxel chemotherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

September 13, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

DE(1)