Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Condition: Hormone-Resistant Prostate Cancer; Stage IV Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Intervention: Cabazitaxel; Prednisone
Intervention description: Given IV; Given PO
Intervention MeSH terms: Prednisone; Cortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well cabazitaxel and prednisone work in treating patients
      with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used
      in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
      stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate adenocarcinoma

          -  Metastatic disease

          -  Able and willing to provide informed consent and to comply with the study procedures

          -  Castration resistant disease defined as evidence of radiological and/or prostate
             specific antigen (PSA) progression despite castrate levels of testosterone (serum
             testosterone < 50 ng/dL [1.7 nmol/L]); for PSA progression, there must be at least 2
             sequential rises at a minimum of 1-week intervals; the first PSA value must be >= 4
             (Prostate Cancer Working Group 2 [PCWG2] criteria)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  At least 21 days have passed since completing radiotherapy (exception for
             radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a
             restricted field or limited-field radiotherapy to non-marrow bearing area such as an
             extremity or orbit) at the time of registration

          -  At least 21 days have passed since receiving any investigational agent at the time of
             registration

          -  At least 21 days have passed since major surgery

          -  Neuropathy =< grade 1 at the time of registration

          -  Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia
             and any signs or symptoms of androgen deprivation therapy) at the time of registration

          -  Poor prognosis disease as defined by any of the following:

               -  PSA nadir >=4.0, or

               -  Gleason score 8-10, or

               -  Time from ADT initiation to CRPC of =< 16 months

          -  Hemoglobin >= 90 g/L

          -  Neutrophils >= 1.5 x 10^9 /L

          -  Platelets >= 100 x 10^9/L

          -  Aspartate aminotransferase (AST) < 1.5 x upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) < 1.5 x ULN

          -  Bilirubin =< 1.0 x ULN (exceptions for Gilbert's syndrome)

          -  Creatinine =< 1.5 x ULN

        Exclusion Criteria:

          -  Prior therapy with cabazitaxel or to other drugs formulated with polysorbate 80

          -  Prior taxanes for CRPC

          -  Prior enzalutamide, abiraterone or ketoconazole

          -  Other condition, illness, psychiatric condition, or laboratory abnormality that may
             increase the risk associated with administration of cabazitaxel, study participation,
             or may interfere with the interpretation of study results and in the judgment of the
             investigator would make the patient inappropriate for entry into this study

          -  Histologic evidence of small cell/neuroendocrine prostate cancer

          -  Patients with reproductive potential who do not agree to use accepted and effective
             method of contraception during the study treatment period and up to 6 months after the
             last administered dose; the definition of "effective method of contraception" will be
             based on the investigator's judgment