Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer (PROSPECTA)
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ClinicalTrials.gov Identifier: NCT01649635 |
Recruitment Status :
Completed
First Posted : July 25, 2012
Last Update Posted : July 6, 2016
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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 |
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Prostate Cancer | Drug: CABAZITAXEL (XRP6258) Drug: Prednisone Drug: Ciprofloxacin Drug: G-CSF (Granulocyte colony-stimulating factor) | Phase 4 |
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 |
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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
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Drug: CABAZITAXEL (XRP6258)
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 |
- Proportion of patients with some episode of neutropenia classified as grade ≥ 3 [ Time Frame: 21 days ]
- Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
- Rate of febrile neutropenia [ Time Frame: up to 24 months (every 21 days) ]
- Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
- PSA response rate [ Time Frame: up to 24 months (every 21 days) ]
- Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 and End of Treatment ]
- 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) ]
- Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT01649635
Brazil | |
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 |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov 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 |
Prostatic Neoplasms Neutropenia Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Ciprofloxacin Prednisone Sargramostim Lenograstim |
Anti-Inflammatory Agents Glucocorticoids Hormones 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 |