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Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer (PROSPECTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649635
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.

Secondary Objectives:

  • PSA response rate;
  • Descriptive assessment of CTC (circulating Tumor Cells);
  • Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
  • Description of the Health Quality of Life of the patients;
  • Incidence of adverse events.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CABAZITAXEL (XRP6258) Drug: Prednisone Drug: Ciprofloxacin Drug: G-CSF (Granulocyte colony-stimulating factor) Phase 4

Detailed Description:
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.
Study Start Date : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
Pharmaceutical form: solution Route of administration: intravenous

Drug: Prednisone
Pharmaceutical form: tablet Route of administration: oral

Drug: Ciprofloxacin
Pharmaceutical form: tablet Route of administration: oral

Drug: G-CSF (Granulocyte colony-stimulating factor)
Pharmaceutical form: solution Route of administration: subcutaneous

Primary Outcome Measures :
  1. Proportion of patients with some episode of neutropenia classified as grade ≥ 3 [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
  2. Rate of febrile neutropenia [ Time Frame: up to 24 months (every 21 days) ]
  3. Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
  4. PSA response rate [ Time Frame: up to 24 months (every 21 days) ]
  5. Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 and End of Treatment ]
  6. Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) [ Time Frame: up to 24 months (every 21 days) ]
  7. Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Histologically proven Castration-Resistant Prostate Cancer (stage IV only);
  • Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.
  • Performance status 0 or 1;

Exclusion criteria:

  • Previous treatment with chemotherapy, except for docetaxel;
  • Previous use of abiraterone;
  • Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy;
  • Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years);
  • Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs
  • History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension;
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol;
  • Known seropositivity for HIV;
  • Presence of significant psychiatric or neurological disease, in the investigator's opinion;
  • Presence of uncontrolled hypercalcemia;
  • Refusal to use appropriate contraception during the study period;
  • Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
  • Inadequate organ and bone marrow function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01649635

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Investigational Site Number 007
Centro, Brazil, 78020-400
Investigational Site Number 004
Curitiba, Brazil, 81520-060
Investigational Site Number 006
Lajeado, Brazil, 95900-000
Investigational Site Number 005
Porto Alegre, Brazil, 90035-903
Investigational Site Number 001
Santo Andre, Brazil, 09050-360
Investigational Site Number 002
São Paulo, Brazil, 01321-001
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Identifier: NCT01649635    
Other Study ID Numbers: CABAZ_L_06003
U1111-1123-9025 ( Other Identifier: UTN )
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Leukocyte Disorders
Hematologic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Adjuvants, Immunologic
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action