Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

SCOPE

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CABAZL07266CABAZL07266

Non-interventional study to evaluate the influence of the sequence in which Cabazitaxel is applied on the outcome of patients with metastatic castration-resistant prostate cancer treated with Cabazitaxel (SCOPE)

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

Primaryobjective:

Evaluate possible dependencies of preceding therapy sequence in patients with mCRPC on the observed progression-freesurvival (PFS)from first cabazitaxel dose on,asassessed by the investigator

Secondary Outcomes

Secondaryobjectives:

  • Number of cabazitaxel cycles received
  • PSA Response of cabazitaxel at the time o fNADIR asdefined as 50%

decline compared to baseline

  • PSA Response of cabazitaxel at the time of NADIR as defined as 30%

decline compared to baseline

  • PSA waterfall plot
  • Time to PSA Progression with each therapy
  • Clinical or radiological PFS with each therapy
  • Response rate according to the investigator's (physician's) assessment based on PSA, pain and/ or Tumor evaluation(if possible according to RECIST) for each therapy
  • Overallsurvivalfrom

-  timepoint offirstmetastaticspread(firstLHRHtherapy)

-  timepoint of castration resistance

-  timepoin to first dosing with endocrine substance (abiraterone

Acetate or enzalutamide)

-  first docetaxel dose

-  timepoint of star tof cabazitaxel therapy

or in addition, the following prognostic factors for Overall survival will be investigated: high PSA value; type of metastasis; number of metastatic sites; low testosterone values; low Hb; high LDH; moderate to low Response to Hormone therapy

  • Safety

Diagnosis

metastatic castrate resistant prostate cancer

Patient attributes

Age

18-99

Inclusion criteria

  • mcrPCA
  • pre-treated with Docetaxel

Exclusion criteria

  • Participation in any other clinical Trial in which administration of IMP

occurred 30 days Prior to enrollment into SCOPE Study

  • Treatment with cabazitaxel Prior to enrollment
  • Patients who cannot be treated with cabazitaxel according to SMPC

Trial design

  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

Treatment with Cabazitaxel after Docetaxel

Documents (password protected)

Responsibilities in overall trial

Sanofi-Aventis

  • Tel. 0033 160497777
  • Fax 033 160497515

Sponsor representative

Dr. Eva Verena Weidemann

National Coordinating Investigator

Dr. Eva Verena Weidemann

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